Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters and balance in patients with Multiple Sclerosis
Design
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.
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; patients who experience cognitive impairment and severe depression; orthopedic disorders that can negatively affect balance.
Intervention groups
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.
Main outcome variables
Balance; gait parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053689N1
Registration date:2022-03-03, 1400/12/12
Registration timing:registered_while_recruiting
Last update:2022-03-03, 1400/12/12
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters and balance 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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Narges Jahantigh Akbari
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bouali Hospital, Damavand St. (New Tehran), Imam Hossein Square, Tehran
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
Narges Jahantigh Akbari
Street address
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bouali Hospital, Damavand St. (New Tehran), Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com
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