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Evaluating the effect of intranasal insulin administration on motor and non-motor symptoms in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial

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History
# Registration date Revision Id
2 2021-02-28, 1399/12/10 173406
1 2019-12-07, 1398/09/16 113051
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  • Protocol summary

    1. Evaluating the effect of intranasal insulin on motor symptoms (gait, balance, bradykinesia, dyskinesia, speech, tremor, rigidity) of Parkinson’s disease 2. Evaluating the effect of intranasal insulin on non-motor symptoms (cognitive, memory, sleep, depression, heart rate, orthostatic blood pressure) of Parkinson’s disease
    1. Evaluating the effect of intranasal insulin on motor symptoms of Parkinson’s disease 2. Evaluating the effect of intranasal insulin on non-motor symptoms of Parkinson’s disease
    1. بررسی اثر تجویز داخل‌بینی انسولین بر علائم حرکتی (راه رفتن، تعادل، برادی‌کینزی، دیس‌کینزی، حرف زدن، ترمور، سختی عضلات) بیماران مبتلا به پارکینسون 2. بررسی اثر تجویز داخل‌بینی انسولین بر علائم غیرحرکتی (اختلالات شناختی، اختلالات حافظه، اختلالات خواب، افسردگی، ضربان قلب، فشارخون وضعیتی) بیماران مبتلا به پارکینسون
    1. بررسی اثر تجویز داخل‌بینی انسولین بر علائم حرکتی بیماران مبتلا به پارکینسون 2. بررسی اثر تجویز داخل‌بینی انسولین بر علائم غیرحرکتی بیماران مبتلا به پارکینسون
    Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly received intranasal placebo or insulin, every day, twice a day for 6 weeks. Motor and non-motor symptoms of patients are evaluated during the study in four times; baseline, 2, 4 and 6 weeks after treatments. Primary outcome is motor symptoms, and secondary outcomes including symptoms cognitive, memory, sleep disorders, depression, heart rate and postural hypertension).
    Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly received intranasal placebo or insulin, every day, twice a day for 6 weeks. Motor and non-motor symptoms of patients are evaluated during the study in four times; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms, and secondary outcomes including symptoms cognitive, memory, sleep disorders, depression, heart rate and postural hypertension).
    بیماران مبتلا به پارکینسون مراجعه‌کننده به درمانگاه اختلالات حرکتی بیمارستان شهدای تجریش به صورت تصادفی دارونما یا انسولین را به مدت 6 هفته، هر روز، روزی دو بار، به صورت داخل بینی دریافت می‌کنند. علائم حرکتی و غیرحرکتی بیماران در طی مطالعه در 4 مرحله مورد ارزیابی قرار می‌گیرند؛ پیش از شروع مطالعه، دو، چهار و شش هفته بعد از درمان. پیامدهای اولیه شامل علائم حرکتی و پیامدهای ثانویه شامل علائم غیرحرکتی (اختلالات شناختی، اختلالات حافظه، اختلالات خواب، افسردگی، ضربان قلب و فشارخون وضعیتی) می‌باشند.
    بیماران مبتلا به پارکینسون مراجعه‌کننده به درمانگاه اختلالات حرکتی بیمارستان شهدای تجریش به صورت تصادفی دارونما یا انسولین را به مدت 6 هفته، هر روز، روزی دو بار، به صورت داخل بینی دریافت می‌کنند. علائم حرکتی و غیرحرکتی بیماران در طی مطالعه در 4 مرحله مورد ارزیابی قرار می‌گیرند؛ پیش از شروع مطالعه، چهار، هشت و دوازده هفته بعد از درمان. پیامدهای اولیه شامل علائم حرکتی و پیامدهای ثانویه شامل علائم غیرحرکتی (اختلالات شناختی، اختلالات حافظه، اختلالات خواب، افسردگی، ضربان قلب و فشارخون وضعیتی) می‌باشند.
    Inclusion criteria: Man and woman over 17 years old; Patient with Parkinson's disease according to UKPDSBB criteria. Exclusion criteria: Pregnant and lactating women; Patients with diabetes and taking anti-hyperglycemic drugs; Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc.; Patients who cannot walk for more than one minute without help.
    Inclusion criteria: Man and woman over 17 years old; Patient with Parkinson's disease according to UKPDSBB criteria; Patients with written informed consent. Exclusion criteria: Pregnant and lactating women; Patients with diabetes and taking anti-hyperglycemic drugs; Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc.; Patients who cannot walk for more than one minute without help; A history of allergic reaction to insulin; The presence of inflammation of nasal cavity.
    شرایط ورود: مرد/ زن بالای 17 سال؛ بیماران مبتلا به بیماری پارکینسون بر اساس معیار UKPDSBB. شرایط عدم ورود: زنان باردار و شیرده؛ بیماران مبتلا به دیابت و مصرف‌کننده داروهای آنتی‌هایپرگلایسمیک؛ بیماران مبتلا به سایر بیماری‌های نورودژنراتیو مثل multiple system atrophy، هانتینگتون، بیماری ویلسون، آلزایمر، ALS، progressive supranuclear palsy و..؛ بیمارانی که بدون کمک قادر به راه رفتن بیش از یک دقیقه نیستند.
    شرایط ورود: مرد/ زن بالای 17 سال؛ بیماران مبتلا به پارکینسون بر اساس معیار UKPDSBB. بیماران دارای فرم رضایت نامه آگاهانه شرایط عدم ورود: زنان باردار و شیرده؛ بیماران مبتلا به دیابت و مصرف‌کننده داروهای آنتی‌هایپرگلایسمیک؛ بیماران مبتلا به سایر بیماری‌های نورودژنراتیو مثل multiple system atrophy، هانتینگتون، بیماری ویلسون، آلزایمر، ALS، progressive supranuclear palsy و..؛ بیمارانی که بدون کمک قادر به راه رفتن بیش از یک دقیقه نیستند؛ سابقه واکنش آلرژیک به انسولین؛ سابقه التهاب حفره بینی.

  • General information

    3
    2
    empty
    1- The phase of the study has been written as phase 3, thus it was been changed. 2- The duration of study was changed from 6 weeks to 12 weeks, and follow up duration was changed from every two weeks to every four weeks. 3- The study has been registered in WWW.clinicaltrials.gov, therefore, its information has added to the profile.
    empty
    1- فاز مطالعه به اشتباه 3 نوشته شده بود، که به 2 تغییر یافت. 2- مدت زمان مصرف دارو 6 هفته تعیین شده بود، با توجه به عدم مشاهده هر گونه عوارض در تعدادی از بیماران وارد شده به مطالعه، مدت زمان درمان به 12 هفته افزایش یافت و پایش (follow up) بیماران از دو هفته یک بار به چهار هفته یک بار تغییر یافت. 3- کارآزمایی در مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov) ثبت شد، درنتیجه اطلاعات مربوط به ثبت آن در پروفایل اضافه شد.
    1. Man and woman over 17 years old
    2. Patient with Parkinson's disease according to UKPDSBB criteria
    3. Patients with the tendency to go to the clinic for visit
    4. Patients with the ability to prescribe medicine for him/herself
    Man and woman over 17 years old
    Patient with Parkinson's disease according to UKPDSBB criteria
    Provide written informed consent to participate in the study
    Understand that they may withdraw their consent at any time.
    1. مرد/ زن بالای 17 سال
    2. بیماران مبتلا به بیماری پارکینسون بر اساس معیار UKPDSBB
    3. بیماران دارای تمایل به مراجعه به کلینیک جهت ویزیت
    4. بیماران دارای توانایی تجویز دارو برای خود
    مرد/ زن بالای 17 سال
    بیماران مبتلا به بیماری پارکینسون بر اساس معیار UKPDSBB
    بیمارانی که فرم رضایت نامه آگاهانه را امضاء کنند.

  • Secondary Ids

    #1
    empty
    مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov)
    empty
    NCT04687878
    empty
    2020-12-29, 1399/10/09

  • Primary outcomes

    #1
    Motor symptoms score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز علائم حرکتی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز علائم حرکتی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله

  • Secondary outcomes

    #1
    Non-motor symptoms score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Non-motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز علائم غیرحرکتی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز علائم غیرحرکتی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #2
    Depression score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Depression score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز افسردگی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز افسردگی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #3
    Anxiety score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Anxiety score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز اضطراب در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز اضطراب در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #4
    fatigue score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    fatigue score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز خستگی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز خستگی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #5
    severity score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    severity score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه گیری امتیاز شدت بیماری در ابتدای مطالع (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه گیری امتیاز شدت بیماری در ابتدای مطالع (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #6
    Cognitive symptoms score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه‌گیری امتیاز علائم شناختی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه‌گیری امتیاز علائم شناختی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #7
    Cognitive symptoms score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه‌گیری امتیاز علائم شناختی در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه‌گیری امتیاز علائم شناختی در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله
    #8
    Falling score at the base line (before initiation the intervention) and 2, 4 and 6 weeks after intervention
    Falling score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
    اندازه‌گیری امتیاز زمین خوردن در ابتدای مطالعه (قبل از شروع مداخله) و 2، 4 و 6 هفته پس از شروع مداخله
    اندازه‌گیری امتیاز زمین خوردن در ابتدای مطالعه (قبل از شروع مداخله) و 4، 8 و 12 هفته پس از شروع مداخله

  • Intervention groups

    #1
    Control group: Placebo, intranasal administration, every day, twice a day, in both sides, 6 week
    Control group: Placebo, intranasal administration, every day, twice a day, in both sides, for 12 weeks
    گروه کنترل: دریافت پلاسبو (دارونما)، تجویز داخل بینی (اسپری)، هر روز، صبح و شب، هر نوبت یک پاف در هر سمت بینی، به مدت 6 هفته
    گروه کنترل: دریافت پلاسبو (دارونما)، تجویز داخل بینی (اسپری)، هر روز، روزی دو بار، هر نوبت یک پاف در هر سمت بینی، به مدت 12 هفته
    #2
    Intervention group: Insulin, 40 IU, intranasal administration, every day, twice a day, in both sides, 6 week
    Intervention group: Insulin, intranasal administration, 40 IU/day, every day, twice a day, in both sides, for 12 weeks
    گروه مداخله: انسولین، 40 واحد، تجویز داخل بینی (اسپری)، هر روز، صبح و شب، هر نوبت یک پاف در هر سمت بینی، به مدت 6 هفته
    گروه مداخله: انسولین، تجویز داخل بینی (اسپری)، 40 واحد در روز، هر روز، روزی دو بار، هر نوبت یک پاف در هر سمت بینی، به مدت 12 هفته

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Neda Valian
    Full name of responsible person - Persian: ندا ولیان
    Position - English: Post doctoral
    Position - Persian: پسا دکترا
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
    Street address - Persian: بزرگراه شهید چمران، خیابان یمن، بلوار دانشجو، مرکز تحقیقات علوم اعصاب دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983963113
    Phone: +98 21 2242 9768
    Mobile: +98 912 034 1595
    Fax:
    Email: n.valian@sbmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Neda Valian
    Full name of responsible person - Persian: ندا ولیان
    Position - English: Assistant professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 63
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
    Street address - Persian: بزرگراه شهید چمران، خیابان یمن، بلوار دانشجو، مرکز تحقیقات علوم اعصاب دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983963113
    Phone: +98 21 2242 9768
    Mobile: +98 912 034 1595
    Fax:
    Email: n.valian@sbmu.ac.ir
    Web page address:

Protocol summary

Study aim
1. Evaluating the effect of intranasal insulin on motor symptoms of Parkinson’s disease 2. Evaluating the effect of intranasal insulin on non-motor symptoms of Parkinson’s disease
Design
This study is a single-center, parallel and double-blind study. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly divided into control and treatment groups.
Settings and conduct
Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly received intranasal placebo or insulin, every day, twice a day for 6 weeks. Motor and non-motor symptoms of patients are evaluated during the study in four times; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms, and secondary outcomes including symptoms cognitive, memory, sleep disorders, depression, heart rate and postural hypertension).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Man and woman over 17 years old; Patient with Parkinson's disease according to UKPDSBB criteria; Patients with written informed consent. Exclusion criteria: Pregnant and lactating women; Patients with diabetes and taking anti-hyperglycemic drugs; Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc.; Patients who cannot walk for more than one minute without help; A history of allergic reaction to insulin; The presence of inflammation of nasal cavity.
Intervention groups
Control (placebo) and insulin groups
Main outcome variables
Score of motor symptoms at Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part III, IV)

General information

Reason for update
1- The phase of the study has been written as phase 3, thus it was been changed. 2- The duration of study was changed from 6 weeks to 12 weeks, and follow up duration was changed from every two weeks to every four weeks. 3- The study has been registered in WWW.clinicaltrials.gov, therefore, its information has added to the profile.
Acronym
IRCT registration information
IRCT registration number: IRCT20191022045196N1
Registration date: 2019-12-07, 1398/09/16
Registration timing: prospective

Last update: 2021-03-02, 1399/12/12
Update count: 1
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Neda Valian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 9768
Email address
n.valian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of intranasal insulin administration on motor and non-motor symptoms in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial
Public title
Evaluating the effect of intranasal insulin administration on motor and non-motor symptoms in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Man and woman over 17 years old Patient with Parkinson's disease according to UKPDSBB criteria Provide written informed consent to participate in the study Understand that they may withdraw their consent at any time.
Exclusion criteria:
1. Pregnant and lactating women 2. Patients with diabetes and taking anti-hyperglycemic drugs 3. Other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc. 4. Patients who cannot walk for more than one minute without help. 5. Patients with history of allergic reactions to insulin 6. Patients with history of nasal cavity inflammation that prevents insulin absorption 7. Patients with kidney and liver diseases
Age
From 17 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researchers (physicians, outcome assessors) and data analysts are not aware about prescribed drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov)
Secondary trial Id
NCT04687878
Registration date
2020-12-29, 1399/10/09

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Public Health and Neuroscience Research Center, Shahid Beheshti Univer
Street address
School of Public Health and Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.SBMU.PHNS.REC.1398.094

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Score of motor symptoms
Timepoint
Motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part III, IV)

Secondary outcomes

1

Description
Score of non-motor symptoms
Timepoint
Non-motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part I, II)

2

Description
Score of depression
Timepoint
Depression score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Beck's Depression Inventory II questionnaire

3

Description
Score of anxiety
Timepoint
Anxiety score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Beck Anxiety Inventory (BAI) questionnaire

4

Description
Score of fatigue severity
Timepoint
fatigue score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Fatigue Severity Scale (FSS) questionnaire

5

Description
Score of disease severity
Timepoint
severity score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Modified Hoehn and Yahr (HY) questionnaire

6

Description
Score of cognitive symptoms
Timepoint
Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Montreal Cognitive Assessment (MOCA) questionnaire

7

Description
Score of cognitive symptoms
Timepoint
Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Scales for Outcomes of Parkinson’s disease-cognition (SCOPA-COG) questionnaire

8

Description
Score of Falling
Timepoint
Falling score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
Method of measurement
Tinetti Balance Assessment Tool questionnaire

Intervention groups

1

Description
Control group: Placebo, intranasal administration, every day, twice a day, in both sides, for 12 weeks
Category
Behavior

2

Description
Intervention group: Insulin, intranasal administration, 40 IU/day, every day, twice a day, in both sides, for 12 weeks
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mehri Salari
Street address
Shohadaye Tajrish Educational Hospital, Tajrish Square, Tehran Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mehri.salari@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Dargahi
Street address
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 9768
Email
l.dargahi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehri Salari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mehri.salari@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Dargahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 9768
Email
l.dargahi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Valian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 9768
Fax
Email
n.valian@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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