History
# Registration date Revision Id
4 2023-09-25, 1402/07/03 280025
3 2023-08-09, 1402/05/18 276381
2 2023-03-24, 1402/01/04 260331
1 2022-03-03, 1400/12/12 218862
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  • Protocol summary

    Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters and balance in patients with Multiple Sclerosis
    Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters, balance and fatigue in patients with Multiple Sclerosis
    مقایسه اثر Cerebellum tDCS و Prefrontal tDCS بر روی پارامترهای گیت و تعادل در بیماران مبتلا به مولتیپل اسکلروزیس
    مقایسه اثر Cerebellum tDCS و Prefrontal tDCS بر روی پارامترهای گیت، تعادل و خستگی در بیماران مبتلا به مولتیپل اسکلروزیس
    Subjects will be randomly divided into two groups, DLPFC tDCS and Cerebellum tDCS. The treatment plan for each of the DLPFC tDCS and Cerebellum tDCS groups will include 20 minutes of brain stimulation with 1.5 mA tDCS and 10 minutes of balance training.
    Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will included 20 minutes of brain stimulation with 1.5 mA tDCS and 10 minutes of balance training.
    افراد مورد مطالعه به 2 گروهDLPFC tDCS و Cerebellum tDCS بصورت تصادفی تقسیم خواهند شد.برنامه درمانی هریک از گروه های DLPFC tDCS و Cerebellum tDCS شامل ۲۰ دقیقه تحریک مغزی با tDCS با شدت 1.5 میلی آمپر و ده دقیقه تمرینات تعادلی خواهد بود.
    افراد مورد مطالعه به 3 گروهDLPFC tDCS ، Cerebellum tDCS و گروه کنترل بصورت تصادفی تقسیم خواهند شد.برنامه درمانی شامل ۲۰ دقیقه تحریک مغزی با tDCS با شدت 1.5 میلی آمپر و ده دقیقه تمرینات تعادلی خواهد بود.
    Inclusion criteria: diagnosis of MS by a neurologist; MS type relapsing remitting and secondary progressive type; the EDSS score should be between 3.5 and 6.5; age range between 18 to 50 years. Exclusion criteria: severe mental and cardiac patients; patients who experience cognitive impairment and severe depression; orthopedic disorders that can negatively affect balance.
    Inclusion criteria: diagnosis of MS by a neurologist; MS type relapsing remitting and secondary progressive type; the EDSS score should be between 3.5 and 6.5; age range between 18 to 50 years. Exclusion criteria: severe mental and cardiac patients; cognitive impairment and severe depression; orthopedic disorders.
    شرایط ورود: تشخیص بیماری ام.اس توسط پزشک متخصص مغز و اعصاب - ام.اس نوع عود کننده و فروکش یابنده و نوع پیشرونده ثانویه - نمره EDSS بین 3.5 تا 6.5 باشد - محدوده سنی بین 18 تا 50 سال. شرایط عدم ورود: بیماران روانی شدید و قلبی - بیمارانی که نقص شناختی و افسردگی شدید را تجربه می کنند - اختلالات ارتوپدی که می توانند بطور منفی تعادل را تحت تاثیر قرار دهند.
    شرایط ورود: تشخیص بیماری ام.اس توسط پزشک متخصص مغز و اعصاب - ام.اس نوع عود کننده و فروکش یابنده و نوع پیشرونده ثانویه - نمره EDSS بین 3.5 تا 6.5 باشد - محدوده سنی بین 18 تا 50 سال. شرایط عدم ورود: بیماران روانی شدید و قلبی - بیمارانی که نقص شناختی و افسردگی شدید را تجربه می کنند - اختلالات ارتوپدی.
    DLPFC tDCS group: In this group, the tDCS anodal is placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region. cerebellum tDCS group: In this group, the tDCS anodal is placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across the ipsilateral muscle of the ipsilateral or supraorbital or forehead area.
    DLPFC tDCS group: The tDCS anodal will placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region. cerebellum tDCS group: The tDCS anodal will placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across buccinator muscle of the same side. In control group: The “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. The electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation. The stimulator will be turned off after 30seconds of stimulation without the participant’s knowledge.
    گروه DLPFC tDCS: در این گروه، آنودال tDCS برای تحریک کورتکس پره فرونتال دورسولترال چپ (left DLPFC) در سرتاسر ناحیه F3 و الکترود رفرانس در سرتاسر ناحیه سوپرااوربیتال راست قرار می گیرد. گروه cerebellum tDCS: در این گروه، آنودال tDCS برای تحریک right مخچه، 1-2 سانتی متر زیر و 3-4 سانتی متر لترال inion (راست) و الکترود رفرانس در سرتاسر عضله بوکسیناتور همان سمت یا ناحیه supraorbital یا foreheadقرار می گیرد.
    گروه DLPFC tDCS: آنودال tDCS برای تحریک کورتکس پره فرونتال دورسولترال چپ (left DLPFC) در سرتاسر ناحیه F3 و الکترود رفرانس در سرتاسر ناحیه سوپرااوربیتال راست قرار می گیرد. گروه cerebellum tDCS: در این گروه، آنودال tDCS برای تحریک right مخچه، 1-2 سانتی متر زیر و 3-4 سانتی متر لترال inion (راست) و الکترود رفرانس در سرتاسر عضله بوکسیناتور همان سمت قرار می گیرد. در گروه tDCS کنترل: «رویکرد محو شدن کوتاه با تحریک کوتاه مدت (FiSsFo)» برای حفظ یکپارچگی کورسازی و در نتیجه ایجاد احساسات اولیه پوستی استفاده خواهد شد. در گروه شم ، در حالی که الکترودها به طور تصادفی در موقعیت های مشابه برای تحریک مخچه یا DLPFC قرار خواهند گرفت، تحریک پس از 30 ثانیه بدون اطلاع شرکت کننده خاموش خواهد شد.
    Balance; gait parameters
    Balance; gait parameters; fatigue
    تعادل - پارامترهای راه رفتن
    تعادل - پارامترهای راه رفتن- خستگی
  • General information

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    Hello I apologize considering that I had the first experience of registering a clinical trial in IRCT. On the other hand, because I had not paid attention to the date of sampling and I had mistakenly entered the start date as 2022-02-09. While in reality, the sampling date of my study was from 2022-03-11, that is, after getting the IRCT code. On the other hand, considering that during that period of time I was busy answering the reviewers' comments, I had not paid attention to this point and unfortunately I did not edit this topic at that time. But now that I have sent my article to some valid journals, they objected to the point that the start date of my sampling is before receiving the IRCT code. At this time, I am sorry to request that the sampling start date of my study be changed to 2022-03-11. Thanks for your help.
    Hello Good time, In the initial study, intervention groups were considered due to time limitations and the number of referring patients. But during the study process, a number of patients were examined as a control group in order to have a better evaluation of the comparison of the results and also to examine the real effect of tDCS. On the other hand, in the control group, the device was turned off. Therefore, it is requested to add the control group, and also according to the addition of the control group, a number should be added to the sample size. Thank you for your kindness, dear colleague.
    با سلام عذر میخوام با توجه به اینکه تجربه اول ثبت کردن کارآزمایی بالینی در IRCT داشتم. از طرفی به دلیل اینکه به تاریخ شروع نمونه گیری توجه نکرده بودم و اشتباها تاریخ شروع رو 1400/11/20 وارد کرده بودم. در حالی که که در واقعیت تاریخ شروع نمونه گیری مطالعه ام از 1400/12/20 یعنی بعد از گرفتن کد IRCT بود. از طرفی با توجه به اینکه در آن بازه زمانی درگیر جواب دادن به کامنت های داوران بودم، به این نکته توجه نکرده بودم و متاسفانه در آن زمان به ویرایش این موضوع نپرداختم. ولی اکنون که مقاله ام رو برای چند ژورنال معتبر فرستادم، به این نکته که تاریخ شروع نمونه گیری ام قبل از دریافت کد IRCT می باشد ایراد گرفته اند. در حال حاضر، با عرض پوزش درخواست من از محضر شما این است که تاریخ شروع نمونه گیری مطالعه ام به 1400/12/20 تغییر یابد. با تشکر از لطف شما.
    با سلام وقتتون بخیر، در مطالعه اولیه به دلیل محدودیت زمانی و تعداد بیماران مراجعه کننده، گروه های مداخله در نظر گرفته شد ولی در طول روند مطالعه، تعدادی از بیماران به عنوان گروه کنترل بررسی شد تا ارزیابی بهتری از مقایسه نتایج و نیز بررسی تاثیر واقعی tDCS داشته باشیم . از طرف دیگر، در گروه کنترل دستگاه خاموش بود. لذا درخواست می گردد گروه کنترل اضافه گردد و همچنین با توجه به اضافه شدن گروه کنترل، تعدادی به حجم نمونه نیز اضافه شود با تشکر از لطف شما همکار محترم.
    Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters and balance in patients with multiple sclerosis
    Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters, balance and fatigue in patients with multiple sclerosis
    مقایسه اثر Cerebellum tDCS و Prefrontal tDCS بر روی پارامترهای گیت و تعادل در بیماران مبتلا به مولتیپل اسکلروزیس
    مقایسه اثر Cerebellum tDCS و Prefrontal tDCS بر روی پارامترهای گیت، تعادل و خستگی در بیماران مبتلا به مولتیپل اسکلروزیس
    For random distribution of samples in intervention group (A) and control (B), to the first client who as Selected available, two balls A and B were given. Based on the selection of the first sample, the other samples, respectively, One in between, they were divided into two groups.
    Patients randomly will be assigned through simple pseudo-randomization procedures using computer-generated list of random numbers to one of the three groups: (1) the group will received a-tDCS over dorsolateral prefrontal cortex and balance training, (2) the group will received a-tDCS over cerebellum and balance training and (3) the control group will received sham a-tDCS and balance training. The pseudo-randomized numbers of 1, 2 and 3 will be applied by one of the researchers to assign individuals to these groups
    برای تقسیم تصادفی نمونه ها در گروه مداخله (A) و کنترل (B) به مراجعه کننده ی اول که به صورت در دسترس انتخاب شده، دو گوی A و B داده شد. بر اساس انتخاب نمونه اول، سایر نمونه ها به ترتیب، یکی در میان در دو گروه، تقسیم شدند.
    بیماران به طور تصادفی از طریق روش های ساده شبه تصادفی سازی با استفاده از لیست اعداد تصادفی تولید شده توسط کامپیوتر به یکی از سه گروه تقسیم خواهند شد: (1) گروه a-tDCS را روی قشر جلوی مغز پشتی جانبی و تمرینات تعادلی دریافت خواهند کرد، (2) گروه a-tDCS بر روی مخچه و تمرین تعادلی و (3) گروه کنترل a-tDCS ساختگی و تمرینات تعادل را دریافت خواهند کرد. اعداد شبه تصادفی 1، 2 و 3 توسط یکی از محققین برای تخصیص افراد به این گروه ها استفاده خواهد شد.
    The data analyzer will be blinded to the allocation of patients to the two groups of intervention and control, and data collection will be done in a separate room to the treatment department also, patients will be blinded depending on the treatment they receive and each of them will be treated in a separate room.
    The data analyzer will be blinded to the allocation of patients to the two groups of intervention and control, and data collection will be done in a separate room to the treatment department also, patients will be blinded depending on the treatment they receive and each of them will be treated in a separate room.
    فرد آنالیز کننده داده نسبت به تخصیص بیماران به دو گروه مداخله و کنترل کورسازی خواهد شد و جمع آوری داده در اتاق جداگانه نسبت به بخش درمان انجام خواهد شد همچنین بیماران نسبن به درمان دریافتی کورسازی خواهند شد و درمان هریک از آنها در اتاق جداگانه از هم انجام خواهد شد.
    آنالیز کننده داده ها نسبت به تخصیص بیماران به یکی از سه گروه های مداخله و کنترل کور خواهند شد و جمع آوری داده ها در اتاقی جداگانه به بخش درمان نیز انجام می شود و بیماران بسته به درمانی که دریافت خواهند کرد، هر کدام از آنها کور خواهند شد.
  • Primary outcomes

    #1
    empty
    Balance
    empty
    تعادل
    empty
    Before intervention-After intervention
    empty
    قبل از مداخله-بعد از مداخله
    empty
    berg balance scale
    empty
    مقیاس تعادل برگ
    #2
    empty
    balance
    empty
    تعادل
    empty
    Before intervention-After intervention
    empty
    قبل از مداخله-بعد از مداخله
    empty
    Timed Up و Go test
    empty
    تست مدت زمان بلند شدن و نشستن
    #3
    empty
    fatigue
    empty
    خستگی
    empty
    Before intervention-After intervention
    empty
    قبل از مداخله- بعد از مداخله
    empty
    Fatigue Severity Scale (FSS)
    empty
    مقیاس شدت خستگی
  • Intervention groups

    #1
    empty
    Rehabilitation
    empty
    Control group: “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. In the sham a-tDCS group, while the electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation, the stimulator will turned off after 30seconds of stimulation without the participant’s knowledge.
    empty
    گروه کنترل: : «رویکرد محو شدن کوتاه با تحریک کوتاه مدت (FiSsFo)» برای حفظ یکپارچگی کورسازی و در نتیجه ایجاد احساسات اولیه پوستی استفاده خواهد شد. در گروه شم ، در حالی که الکترودها به طور تصادفی در موقعیت های مشابه برای تحریک مخچه یا DLPFC قرار خواهند گرفت، تحریک پس از 30 ثانیه بدون اطلاع شرکت کننده خاموش خواهد شد.

Protocol summary

Study aim
Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters, balance and fatigue in patients with Multiple Sclerosis
Design
Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will included 20 minutes of brain stimulation with 1.5 mA tDCS and 10 minutes of balance training.
Settings and conduct
Men and women with MS living in Tehran who voluntarily want to participate in this study and meet the inclusion criteria, constitute the statistical population. This double-blind randomized clinical trial will be performed at Shahid Beheshti School of Rehabilitation of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of MS by a neurologist; MS type relapsing remitting and secondary progressive type; the EDSS score should be between 3.5 and 6.5; age range between 18 to 50 years. Exclusion criteria: severe mental and cardiac patients; cognitive impairment and severe depression; orthopedic disorders.
Intervention groups
DLPFC tDCS group: The tDCS anodal will placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region. cerebellum tDCS group: The tDCS anodal will placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across buccinator muscle of the same side. In control group: The “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. The electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation. The stimulator will be turned off after 30seconds of stimulation without the participant’s knowledge.
Main outcome variables
Balance; gait parameters; fatigue

General information

Reason for update
Hello Good time, In the initial study, intervention groups were considered due to time limitations and the number of referring patients. But during the study process, a number of patients were examined as a control group in order to have a better evaluation of the comparison of the results and also to examine the real effect of tDCS. On the other hand, in the control group, the device was turned off. Therefore, it is requested to add the control group, and also according to the addition of the control group, a number should be added to the sample size. Thank you for your kindness, dear colleague.
Acronym
IRCT registration information
IRCT registration number: IRCT20220111053689N1
Registration date: 2022-03-03, 1400/12/12
Registration timing: prospective

Last update: 2023-08-23, 1402/06/01
Update count: 3
Registration date
2022-03-03, 1400/12/12
Registrant information
Name
narges jahantigh akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 8496
Email address
n.jahantigh.akbari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
2022-03-11, 1400/12/20
Actual recruitment end date
2023-01-20, 1401/10/30
Trial completion date
empty
Scientific title
Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters, balance and fatigue in patients with multiple sclerosis
Public title
Comparison of the effect of cerebellum tDCS and prefrontal in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS by a neurologist Relapsing Remitting MS and secondary progressive MS The EDSS score should be between 3.5 to 5
Exclusion criteria:
Severe mental and cardiac patients Patients who experience severe cognitive impairment and depression Orthopedic disorders that can negatively affect balance
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 51
Actual sample size reached: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly will be assigned through simple pseudo-randomization procedures using computer-generated list of random numbers to one of the three groups: (1) the group will received a-tDCS over dorsolateral prefrontal cortex and balance training, (2) the group will received a-tDCS over cerebellum and balance training and (3) the control group will received sham a-tDCS and balance training. The pseudo-randomized numbers of 1, 2 and 3 will be applied by one of the researchers to assign individuals to these groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyzer will be blinded to the allocation of patients to the two groups of intervention and control, and data collection will be done in a separate room to the treatment department also, patients will be blinded depending on the treatment they receive and each of them will be treated in a separate room.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Imam Hossein Square, Damavand St. (New Tehran), in front of Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2021-11-07, 1400/08/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.499

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
8A40
ICD-10 code description
Multiple sclerosis or other white matter disorders

Primary outcomes

1

Description
Balance
Timepoint
Before intervention-After intervention
Method of measurement
Force plate

2

Description
Gait parameters
Timepoint
Before intervention-After intervention
Method of measurement
Motion analyze

3

Description
Balance
Timepoint
Before intervention-After intervention
Method of measurement
berg balance scale

4

Description
balance
Timepoint
Before intervention-After intervention
Method of measurement
Timed Up و Go test

5

Description
fatigue
Timepoint
Before intervention-After intervention
Method of measurement
Fatigue Severity Scale (FSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: in this group, the anodal tDCS is placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region.
Category
Rehabilitation

2

Description
Intervention group 2: in this group, the tDCS anodal is placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across the ipsilateral muscle of the ipsilateral or supraorbital or forehead area.
Category
Rehabilitation

3

Description
Control group: “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. In the sham a-tDCS group, while the electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation, the stimulator will turned off after 30seconds of stimulation without the participant’s knowledge.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Narges Jahantigh Akbari
Street address
Imam Hossein Hospital, at the beginning of Shahid Madani Street, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
zarghi@sbmu.ac.ir
Grant name
Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Afshin Zarghi
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
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com

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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