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Protocol summary
In this study we aim to evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on motor symptoms of patients with essential tremor. We will recruit at least 30 subjects who have diagnosed as essential tremor based on the Movement Disorder Society criteria with involvement of at least one hand among patients visiting at the Specialty Clinic of Mashhad Medical University and after signing a written informed consent, will randomly be assigned to either real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with earplugs during both real and sham stimulations. After 2 months of follow-up, patients will undergo crossover and receive the other treatment as described above. Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after each real or sham treatment session by a blinded researcher. Data will be analysed by another researcher who is also blind.
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In this study we aim to evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on motor symptoms of patients with essential tremor. We will recruit at least 30 subjects who have diagnosed as essential tremor based on the Movement Disorder Society criteria with involvement of at least one hand among patients visiting at the Specialty Clinic of Mashhad Medical University and after signing a written informed consent, will randomly be assigned to either real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with earplugs during both real and sham stimulations. After 2 months of follow-up, patients will undergo crossover and receive the other treatment as described above. Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after each real or sham treatment session by a blinded researcher. Data will be analysed by another researcher who is also blind.
در این مطالعه در نظر داریم تا تاثیر تحریک مکرر مغناطیسی فرا جمجمه ای (rTMS) مخچه را بر شدت علایم حرکتی در بیماران مبتلا به ترمور اساسی بررسی نماییم. به این منظور، تعداد حداقل ۳۰ بیمار مبتلا به ترمور اساسی بر اساس معیارهای جامعه اختلالات حرکتی (Movement Disorder Society) و درگیری حداقل یک دست، از میان مراجعه کنندگان به کلینیک تخصصی بیمارستان قائم مشهد نمونه گیری شده و پس از اخذ رضایت به صورت رندم به دو گروه تقسیم می شوند. درمان با rTMS به میزان ۹۰۰ پالس با فرکانس یک هرتز به مدت ۵ روز و درمان sham با فرکانس و میزان پالس مشابه اما با استفاده از تحریک الکتریکی (حداکثر ۳ میلی آمپر) با استفاده از یک دستگاه کوچک غیر قابل مشاهده توسط بیمار که بر روی کویل سوار می شود انجام شده و پس از یک دوره واش اوت ۲ ماهه بیماران مجدد به صورت متقاطع وارد مطالعه می شوند. ابزار ارزیابی مقیاس فان-تولوسا-مارین بوده و همه بیماران در روزهای ۱ (پیش از مداخله)، ۵، ۱۲ و ۳۰ مورد ارزیابی قرار خواهند گرفت. پر کردن پرسشنامه توسط پزشک دیگری که نسبت به نوع مداخله کور میباشد انجام شده و آنالیز آماری نیز با استفاده از کد و بصورت کورسازی شده انجام میگردد.
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در این مطالعه در نظر داریم تا تاثیر تحریک مکرر مغناطیسی فرا جمجمه ای (rTMS) مخچه را بر شدت علایم حرکتی در بیماران مبتلا به ترمور اساسی بررسی نماییم. به این منظور، تعداد حداقل ۳۰ بیمار مبتلا به ترمور اساسی بر اساس معیارهای جامعه اختلالات حرکتی (Movement Disorder Society) و درگیری حداقل یک دست، از میان مراجعه کنندگان به کلینیک تخصصی بیمارستان قائم مشهد نمونه گیری شده و پس از اخذ رضایت به صورت رندم به دو گروه تقسیم می شوند. درمان با rTMS به میزان ۹۰۰ پالس با فرکانس یک هرتز به مدت ۵ روز و درمان sham با فرکانس و میزان پالس مشابه اما با استفاده از تحریک الکتریکی (حداکثر ۳ میلی آمپر) با استفاده از یک دستگاه کوچک غیر قابل مشاهده توسط بیمار که بر روی کویل سوار می شود انجام شده و پس از یک دوره واش اوت ۲ ماهه بیماران مجدد به صورت متقاطع وارد مطالعه می شوند. ابزار ارزیابی مقیاس فان-تولوسا-مارین بوده و همه بیماران در روزهای ۱ (پیش از مداخله)، ۵، ۱۲ و ۳۰ مورد ارزیابی قرار خواهند گرفت. پر کردن پرسشنامه توسط پزشک دیگری که نسبت به نوع مداخله کور میباشد انجام شده و آنالیز آماری نیز با استفاده از کد و بصورت کورسازی شده انجام میگردد.
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To evaluate the effectiveness of low frequency repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on essential tremor
To evaluate the effectiveness of low frequency repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on essential tremor
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بررسی تاثیر تحریک مکرر مغناطیسی فرا جمجمه ای (rTMS) مخچه بر شدت علایم حرکتی در بیماران مبتلا به ترمور اساسی
بررسی تاثیر تحریک مکرر مغناطیسی فرا جمجمه ای (rTMS) مخچه بر شدت علایم حرکتی در بیماران مبتلا به ترمور اساسی
Patients visited at the Neurology Specialty Clinic of Mashhad Medical University. patients and outcome assessor were blinded.
Patients visited at the Neurology Specialty Clinic of Mashhad Medical University. patients and outcome assessor were blinded.
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مراجعه کنندگان به کلینیک تخصصی بیمارستان قائم مشهد. کورسازی در بیماران و ارزیابی کننده پیامد انجام شد.
مراجعه کنندگان به کلینیک تخصصی بیمارستان قائم مشهد. کورسازی در بیماران و ارزیابی کننده پیامد انجام شد.
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Inclusion criteria: having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand; 18 years or above; cognitively eligible to give informed consent of participation in the trial.
Exclusion criteria: Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI; skin defect at the occipital area preventing placement of a coil; Currently pregnant or plan for pregnancy in the next 6 months; History of seizure; Other comorbid medical conditions capable of producing or enhancing tremor; advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention; Use of new drugs with potential effect on tremor
Inclusion criteria: having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand; 18 years or above; cognitively eligible to give informed consent of participation in the trial. Exclusion criteria: Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI; skin defect at the occipital area preventing placement of a coil; Currently pregnant or plan for pregnancy in the next 6 months; History of seizure; Other comorbid medical conditions capable of producing or enhancing tremor; advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention; Use of new drugs with potential effect on tremor
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ابتلا به ترمور اساسی بر مبنای معیارهای MDS (پیوست شده در ضمیمه) با درگیری حداقل یک دست؛ سن بالای ۱۸ سال؛ رضایت برای شرکت در مطالعه؛ وجود سلامت عقلی جهت ارائه رضایت آگاهانه شرکت در مطالعه
معیارهای خروج: وجود پیس میکر قلبی و سایر کنترا اندیکاسیونهای انجام MRI؛ وجود ضایعات پوستی جدی و ممانعت کننده جاگذاری کویل در ناحیه پس سر؛ بارداری؛ سابقه تشنج؛ مصرف داروهای ایجاد کننده ترمور؛ ابتلا به بیماریهای طبی به جز ترمور اساسی که بتواند ترمور ایجاد کند
ابتلا به بیماری پیشرفته قلبی یا کلیوی یا کبدی و یا سایر بیماریهای ناتوان کننده که مانع تحمل بیمار برای مراجعه یا انجام تحریک مغزی شود؛ مصرف داروی جدید یا اضافه شدن داروهای مصرفی قبلی که تاثیر بر ترمور دارند
ابتلا به ترمور اساسی بر مبنای معیارهای MDS (پیوست شده در ضمیمه) با درگیری حداقل یک دست؛ سن بالای ۱۸ سال؛ رضایت برای شرکت در مطالعه؛ وجود سلامت عقلی جهت ارائه رضایت آگاهانه شرکت در مطالعه معیارهای خروج: وجود پیس میکر قلبی و سایر کنترا اندیکاسیونهای انجام MRI؛ وجود ضایعات پوستی جدی و ممانعت کننده جاگذاری کویل در ناحیه پس سر؛ بارداری؛ سابقه تشنج؛ مصرف داروهای ایجاد کننده ترمور؛ ابتلا به بیماریهای طبی به جز ترمور اساسی که بتواند ترمور ایجاد کند ابتلا به بیماری پیشرفته قلبی یا کلیوی یا کبدی و یا سایر بیماریهای ناتوان کننده که مانع تحمل بیمار برای مراجعه یا انجام تحریک مغزی شود؛ مصرف داروی جدید یا اضافه شدن داروهای مصرفی قبلی که تاثیر بر ترمور دارند
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900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days
900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days
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۹۰۰ پالس تحریک مکرر مغناطیسی فراجمجمه ای هر نیمکره مخچه با شدت ۹۰٪ از ترشولد حرکتی استراحتی روزانه برای ۵ روز پیاپی
۹۰۰ پالس تحریک مکرر مغناطیسی فراجمجمه ای هر نیمکره مخچه با شدت ۹۰٪ از ترشولد حرکتی استراحتی روزانه برای ۵ روز پیاپی
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Tremor severity based on Fahn-Tolosa-Marin scale
Tremor severity based on Fahn-Tolosa-Marin scale
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شدت ترمور بر اساس مقیاس فان-تولوسا-مارین
شدت ترمور بر اساس مقیاس فان-تولوسا-مارین
General information
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18
18
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Year
year
Yes
No
1
Triple blinded
Double blinded
tripldoubl
1
1
1
1
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23
23
2016-04-10, 1395/01/22
2016-05-21, 1395/03/01
2016-0405-1021 00:00:00
2017-05-31, 1396/03/10
2017-05-22, 1396/03/01
2017-05-3122 00:00:00
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2016-05-21, 1395/03/01
2016-05-21 00:00:00
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2017-11-22, 1396/09/01
2017-11-22 00:00:00
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2018-03-22, 1397/01/02
2018-03-22 00:00:00
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To update the trial status
To update the trial status
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به روز رسانی وضعیت ترایال
به روز رسانی وضعیت ترایال
Having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria
Involvement of at least one hand
Cognitively eligible to give informed consent of participation in the trial
18 years or above
Having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria Involvement of at least one hand Cognitively eligible to give informed consent of participation in the trial 18 years or above
ابتلا به ترمور اساسی بر مبنای معیارهای MDS (پیوست شده در ضمیمه)
درگیری حداقل یک دست
سن بالای ۱۸ سال
وجود سلامت عقلی جهت ارائه رضایت آگاهانه شرکت در مطالعه
ابتلا به ترمور اساسی بر مبنای معیارهای MDS (پیوست شده در ضمیمه) درگیری حداقل یک دست سن بالای ۱۸ سال وجود سلامت عقلی جهت ارائه رضایت آگاهانه شرکت در مطالعه
Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI
Skin defect at the occipital area preventing placement of a coil
Currently pregnant or plan for pregnancy in the next 6 months
History of seizure
Other comorbid medical conditions capable of producing or enhancing tremor
Advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention
Use of new medications with potential effect on tremor
Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI Skin defect at the occipital area preventing placement of a coil Currently pregnant or plan for pregnancy in the next 6 months History of seizure Other comorbid medical conditions capable of producing or enhancing tremor Advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention Use of new medications with potential effect on tremor
وجود پیس میکر قلبی و سایر کنترا اندیکاسیونهای انجام MRI بدون کنتراست
وجود ضایعات پوستی جدی و ممانعت کننده جاگذاری کویل در ناحیه پس سر
بارداری یا قصد بارداری در ۶ ماه آینده و عدم پیشگیری
سابقه تشنج
ابتلا به بیماریهای طبی به جز ترمور اساسی که بتواند ترمور ایجاد کند
ابتلا به بیماری پیشرفته قلبی یا کلیوی یا کبدی و یا سایر بیماریهای ناتوان کننده که مانع تحمل بیمار برای مراجعه یا انجام تحریک مغزی شود
مصرف داروی جدید یا اضافه شدن داروهای مصرفی قبلی که تاثیر بر ترمور دارند
وجود پیس میکر قلبی و سایر کنترا اندیکاسیونهای انجام MRI بدون کنتراست وجود ضایعات پوستی جدی و ممانعت کننده جاگذاری کویل در ناحیه پس سر بارداری یا قصد بارداری در ۶ ماه آینده و عدم پیشگیری سابقه تشنج ابتلا به بیماریهای طبی به جز ترمور اساسی که بتواند ترمور ایجاد کند ابتلا به بیماری پیشرفته قلبی یا کلیوی یا کبدی و یا سایر بیماریهای ناتوان کننده که مانع تحمل بیمار برای مراجعه یا انجام تحریک مغزی شود مصرف داروی جدید یا اضافه شدن داروهای مصرفی قبلی که تاثیر بر ترمور دارند
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Block randomization using sealed envelops
Block randomization using sealed envelops
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رندم سازی بلوک با پاکت تیره رنگ مهروموم شده- محتویات پاکت قابل مشاهده نیست
رندم سازی بلوک با پاکت تیره رنگ مهروموم شده- محتویات پاکت قابل مشاهده نیست
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Participants: by use of sham procedure
Outcome assessor: an investigator blinded to the type of intervention assessed outcome and another investigator performed data entry and analysis
Participants: by use of sham procedure Outcome assessor: an investigator blinded to the type of intervention assessed outcome and another investigator performed data entry and analysis
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بیماران: با استفاده درمان شم (دروغین)
ارزیابی کننده پیامد: یکی از محققین که نسبت به نوع مداخله ارایه شده کور نگه داشته شده ارزیابی پیامد اصلی را انجام داده و محقق دیگری داده ها را وارد و آنالیز می کند
بیماران: با استفاده درمان شم (دروغین) ارزیابی کننده پیامد: یکی از محققین که نسبت به نوع مداخله ارایه شده کور نگه داشته شده ارزیابی پیامد اصلی را انجام داده و محقق دیگری داده ها را وارد و آنالیز می کند
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Secondary Ids
#1
2016-03-09, 1394/12/19
2016-03-10, 1394/12/20
2016-03-0910 00:00:00
Ethics committees
#1
2015-09-23, 1394/07/01
2015-10-07, 1394/07/15
2015-0910-2307 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Department of Neurology, Ghaem Hospital
Name of recruitment center - Persian: گروه مغز و اعصاب - بیمارستان قائم
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Street address - English: Department of Neurology, Ghaem hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Department of Neurology, Ghaem Hospital
Name of recruitment center - Persian: گروه مغز و اعصاب - بیمارستان قائم
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Street address - English: Department of Neurology, Ghaem hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9176699199
Phone: +98 51 3842 9828
Fax:
Email: olfatin@mums.ac.ir
Web page address:
Name of recruitment center - English: Department of Neurology, Ghaem Hospital Name of recruitment center - Persian: گروه مغز و اعصاب - بیمارستان قائم Full name of responsible person - English: Nahid Olfati Full name of responsible person - Persian: ناهید الفتی Street address - English: Department of Neurology, Ghaem hospital, Ahmad-abad st. Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9176699199 Phone: +98 51 3842 9828 Fax: Email: olfatin@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Research Vice Chancellor of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: دكتر محسن تفقدی
Street address - English: Research Vice Chancellor of Mashhad University of Medical Sciences, Sakhtemean -e- Ghoreishi, Daneshgah st.
Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- دانشگاه علوم پزشکی مشهد- معاونت پژوهش و فناوری دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Vice Chancellor of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: دكتر محسن تفقدی
Street address - English: Research Vice Chancellor of Mashhad University of Medical Sciences, Sakhtemean -e- Ghoreishi, Daneshgah st.
Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- دانشگاه علوم پزشکی مشهد- معاونت پژوهش و فناوری دانشگاه
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 91357345
Phone: +98 51 3841 2081
Fax:
Email: vcresearch@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research Vice Chancellor of Mashhad University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Mohsen Tafaghodi Full name of responsible person - Persian: دكتر محسن تفقدی Street address - English: Research Vice Chancellor of Mashhad University of Medical Sciences, Sakhtemean -e- Ghoreishi, Daneshgah st. Street address - Persian: خیابان دانشگاه- جنب سینما هویزه- دانشگاه علوم پزشکی مشهد- معاونت پژوهش و فناوری دانشگاه City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91357345 Phone: +98 51 3841 2081 Fax: Email: vcresearch@mums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Position - English: Resident of Neurology
Position - Persian: دستیار تخصصی مغز و اعصاب
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3842 9828
Mobile: 00989153871149153871149
Fax: +98 51 3842 9828
Email: olfatin921@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Position - English: Neurologist
Position - Persian: متخصص مغز و اعصاب
Latest degree: specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3842 9828
Mobile: +98 915 387 1149
Fax: +98 51 3842 9828
Email: olfatin@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب Full name of responsible person - English: Nahid Olfati Full name of responsible person - Persian: ناهید الفتی Position - English: Resident of NeurologyNeurologist Position - Persian: دستیار تخصصیمتخصص مغز و اعصاب Latest degree: specialist Area of specialty/work: 086 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st. Street address - Persian: خیابان احمد آباد، بیمارستان قائم، دفتر گروه مغز و اعصاب City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-99199 Phone: +98 51 3842 9828 Mobile: 00989153871149153871149+98 915 387 1149 Fax: +98 51 3842 9828 Email: olfatin921olfatin@mums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Ali Shoeibi
Full name of responsible person - Persian: علی شعیبی
Position - English: Associate Professor of Neurology
Position - Persian: دانشیار نورولوژی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3842 9828
Mobile: 00
Fax:
Email: shoeibia@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Ali Shoeibi
Full name of responsible person - Persian: علی شعیبی
Position - English: Associate Professor of Neurology
Position - Persian: دانشیار نورولوژی
Latest degree: sub_specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمد آباد، بیمارستان قائم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3842 9828
Mobile: +98 915 513 7344
Fax:
Email: shoeibia@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب Full name of responsible person - English: Ali Shoeibi Full name of responsible person - Persian: علی شعیبی Position - English: Associate Professor of Neurology Position - Persian: دانشیار نورولوژی Latest degree: sub_specialist Area of specialty/work: 086 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st. Street address - Persian: خیابان احمد آباد، بیمارستان قائم City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-99199 Phone: +98 51 3842 9828 Mobile: 00+98 915 513 7344 Fax: Email: shoeibia@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Position - English: Resident of Neurology
Position - Persian: دستیار تخصصی مغز و اعصاب
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمدآباد، بیمارستان قائم
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: +98 51 3842 9828
Mobile: +98 915 387 1149
Fax: +98 51 3842 9828
Email: olfatin921@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب
Full name of responsible person - English: Nahid Olfati
Full name of responsible person - Persian: ناهید الفتی
Position - English: Neurologist
Position - Persian: متخصص مغز و اعصاب
Latest degree: specialist
Area of specialty/work: 86
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Street address - Persian: خیابان احمدآباد، بیمارستان قائم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 91766-99199
Phone: 009851384 9828
Mobile: +98 915 387 1149
Fax: +98 51 3842 9828
Email: olfatin@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Department of Neurology, Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد، گروه مغز و اعصاب Full name of responsible person - English: Nahid Olfati Full name of responsible person - Persian: ناهید الفتی Position - English: Resident of NeurologyNeurologist Position - Persian: دستیار تخصصیمتخصص مغز و اعصاب Latest degree: specialist Area of specialty/work: 086 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Neurology, Ghaem Hospital, Ahmad-abad st. Street address - Persian: خیابان احمدآباد، بیمارستان قائم City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91766-99199 Phone: +98 51 3842009851384 9828 Mobile: +98 915 387 1149 Fax: +98 51 3842 9828 Email: olfatin921olfatin@mums.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
undecided
undecided
yes
yes
na
na
na
na
empty
Data file is available along with the submitted manuscript
Data file is available along with the submitted manuscript
empty
داده های کدگذاری شده در زمان سابمیت مقاله حاصل از ترایال در سایت مجله بارگزاری شده است
داده های کدگذاری شده در زمان سابمیت مقاله حاصل از ترایال در سایت مجله بارگزاری شده است
empty
Anonymized data is available open access
Anonymized data is available open access
empty
داده ها به صورت دسترسی آزاد منتشر شده است
داده ها به صورت دسترسی آزاد منتشر شده است
empty
open access
open access
empty
دسترسی آزاد
دسترسی آزاد
empty
Academics might use data provided that funding sources are cited and contacted
Academics might use data provided that funding sources are cited and contacted
empty
استفاده از داده ها با اطلاع تامین کننده مالی (دانشگاه علوم پزشکی مشهد) و با ارجاع به ان توسط پژوهشگران بلامانع است
استفاده از داده ها با اطلاع تامین کننده مالی (دانشگاه علوم پزشکی مشهد) و با ارجاع به ان توسط پژوهشگران بلامانع است
empty
contact publisher of our final manuscript
contact publisher of our final manuscript
empty
تماس با ناشر گزارش نهایی
تماس با ناشر گزارش نهایی
empty
doi:10.1016/j.brs.2019.10.003
or contact corresponding author shoeibia@mums.ac.ir
doi:10.1016/j.brs.2019.10.003 or contact corresponding author shoeibia@mums.ac.ir
empty
doi:10.1016/j.brs.2019.10.003
یا تماس با نویسنده مسئول: shoeibia@mums.ac.ir
doi:10.1016/j.brs.2019.10.003 یا تماس با نویسنده مسئول: shoeibia@mums.ac.ir
Protocol summary
Study aim
To evaluate the effectiveness of low frequency repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on essential tremor
Patients visited at the Neurology Specialty Clinic of Mashhad Medical University. patients and outcome assessor were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand; 18 years or above; cognitively eligible to give informed consent of participation in the trial.
Exclusion criteria: Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI; skin defect at the occipital area preventing placement of a coil; Currently pregnant or plan for pregnancy in the next 6 months; History of seizure; Other comorbid medical conditions capable of producing or enhancing tremor; advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention; Use of new drugs with potential effect on tremor
Intervention groups
900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days
Main outcome variables
Tremor severity based on Fahn-Tolosa-Marin scale
General information
Reason for update
To update the trial status
Acronym
Cerebellar rTMS for essential tremor
IRCT registration information
IRCT registration number:IRCT2015100824428N1
Registration date:2016-04-01, 1395/01/13
Registration timing:prospective
Last update:2019-12-25, 1398/10/04
Update count:1
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Nahid Olfati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
olfatin921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor, Mashhad University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
2018-03-22, 1397/01/02
Scientific title
Assessing clinical effectiveness of cerebellar repetitive transcranial magnetic stimulation (rTMS) on severity of motor signs of essential tremor.
Public title
Assessing the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) of the cerebellum in treatment of essential tremor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria
Involvement of at least one hand
Cognitively eligible to give informed consent of participation in the trial
18 years or above
Exclusion criteria:
Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI
Skin defect at the occipital area preventing placement of a coil
Currently pregnant or plan for pregnancy in the next 6 months
History of seizure
Other comorbid medical conditions capable of producing or enhancing tremor
Advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention
Use of new medications with potential effect on tremor
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using sealed envelops
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: by use of sham procedure
Outcome assessor: an investigator blinded to the type of intervention assessed outcome and another investigator performed data entry and analysis
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02704793
Registration date
2016-03-10, 1394/12/20
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Mashhad University of Medical Sciences
Street address
Sakhteman-e-Ghoreishi, Daneshgah St., Research Ethics Committee
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
ir.mums.sm.rec.1394.353
Health conditions studied
1
Description of health condition studied
Essential Tremor
ICD-10 code
G25.0
ICD-10 code description
Essential Tremor
Primary outcomes
1
Description
Tremor severity
Timepoint
At the baseline and on days 5, 12, 30 after each real or sham treatment session
Method of measurement
Fahn-Tolosa-Marin scale
Secondary outcomes
empty
Intervention groups
1
Description
Sham treatment (electrical stimulation of less than 3 mili amperes) using a small device located on the coil, invisible to the patient, providing 900 pulses on each cerebellar hemisphere daily for 5 days.
Category
Placebo
2
Description
Bilateral Cerebellar rTMS using the butterfly coil providing 900 pulses on each cerebellar hemispheres daily for 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurology, Ghaem Hospital
Full name of responsible person
Nahid Olfati
Street address
Department of Neurology, Ghaem hospital, Ahmad-abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3842 9828
Email
olfatin@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research Vice Chancellor of Mashhad University of Medical Sciences, Sakhtemean -e- Ghoreishi, Daneshgah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Nahid Olfati
Position
Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3842 9828
Fax
+98 51 3842 9828
Email
olfatin@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Position
Associate Professor of Neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3842 9828
Fax
Email
shoeibia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Nahid Olfati
Position
Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
009851384 9828
Fax
+98 51 3842 9828
Email
olfatin@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data file is available along with the submitted manuscript
When the data will become available and for how long
Anonymized data is available open access
To whom data/document is available
open access
Under which criteria data/document could be used
Academics might use data provided that funding sources are cited and contacted
From where data/document is obtainable
contact publisher of our final manuscript
What processes are involved for a request to access data/document
doi:10.1016/j.brs.2019.10.003
or contact corresponding author shoeibia@mums.ac.ir