Comparison of the effect of using simultaneous or single anodal tDCS on the dorsolateral pre frontal cortex area( DLPFC) and cerebellum on neuromodulation, balance and gait in people with relapsing-remitting multiple sclerosis: a double-blind clinical study
Comparison of the effect of simultaneous direct current stimulation of the DLPFC and Cerebellum cortex, stimulation of the cerebellum and DLPFC alone on neuromodulatation , balance, walking, spasticity and fatigue of people with multiple sclerosis along with task-oriented exercises
Design
Randomized clinical trial without control group, with parallel groups, double-blind. For randomization, the block size of four will be used for randomization, and the sequences will be calculated by the random assignment software version 2.0.
Settings and conduct
The diagnosis will be made at the MS Research Center of Imam Khomeini Hospital and the treatment will be made at the Research Center of the Rehabilitation Faculty of Shahid Beheshti University of Medical Sciences. First, the course of the disease will be diagnosed by a neurologist. In this study, people with multiple sclerosis, the person evaluating the outcome and the person evaluating the results are blind to the treatment groups.tDCS in all three groups (first group of task-oriented training + a-tDCSCB/DLPFC) / second group (task-oriented training + a-tDCSCB) / third group (task-oriented training + a-tDCS DLPFC) in the amount of 2 mA and twenty minutes will be received.The exercises will be done for four weeks (3 times a week and a total of 12 sessions) along with tDCS.
Participants/Inclusion and exclusion criteria
1- Age between 55-20 years
2- Existence of relapsing-remitting MS
3- An attack caused by multiple sclerosis during the last month; Not being in the stable phase of MS
4- Not suffering from other neurological disorders
5-Inability to stand or walk with or without the use of an assistive device
Intervention groups
First group (task-oriented training + a-tDCS CB/DLPFC) / second group (task-oriented training + a-tDCSCB) / third group (task-oriented training + a-tDCS DLPFC)
Main outcome variables
Balance by TUG test
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20200125046249N2
Registration date:2025-05-01, 1404/02/11
Registration timing:prospective
Last update:2025-05-01, 1404/02/11
Update count:0
Registration date
2025-05-01, 1404/02/11
Registrant information
Name
Faezeh Abaschian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 7971
Email address
faezeh_abaschian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using simultaneous or single anodal tDCS on the dorsolateral pre frontal cortex area( DLPFC) and cerebellum on neuromodulation, balance and gait in people with relapsing-remitting multiple sclerosis: a double-blind clinical study
Public title
Comparison of the effect of using simultaneous or single anodal tDCS on the dorsolateral pre frontal cortex area( DLPFC) and cerebellum on brain neuromodulatation, balance and gait in people with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-55 years old
Presence of relapsing-remitting MS
The average level of disability is between 2 and 5 in EDSS
Having at least third middle school education in order to fill out the questionnaires
Receiving stable drug treatments in the last 6 months
Having a balance disorder based on the timed up and go test
Absence of fixed contract
not suffering from other neurological disorders
Absence of obvious postural disorders in the spine
No history of lower limb surgery
Absence of cardiovascular diseases and diabetes
Absence of any intracranial metal implants or other implanted devices such as pacemakers, cochlear implants
Inability to stand or walk with or without the use of an assistive device
Exclusion criteria:
Multiple sclerosis attack within the last month
Not being in the stable phase of MS
pregnancy
Dissatisfaction with treatment
Inability to stand or walk with or without the use of an assistive device
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible cases will be randomly assigned to three tDCS groups of cerebellum and dorsolateral prefrontal cortex or cerebellum and dorsolateral prefrontal cortex, each one alone with block randomization. A block size of four will be used for randomization, and sequences will be calculated by random assignment software version 2.0. Coordinators will have exclusive access to the numbered and sealed envelopes that will indicate each patient's treatment assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know which group they are in and what intervention they are receiving. Also, the outcome assessor and data analyst do not know about the allocation of groups.
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
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2024-12-14, 1403/09/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.511
Health conditions studied
1
Description of health condition studied
Multiple sclerosis(MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Balance score in Timed up and go test
Timepoint
Balance measurement at the beginning of the study (before the start of the intervention) and after 4 weeks and one month after the last treatment session
Method of measurement
Timed up and go test (TUG)
Secondary outcomes
1
Description
Investigating static balance along with cognitive work through pressure point fluctuations on the force plate
Timepoint
Measuring static balance along with cognitive work at the beginning of the study (before the start of the intervention) and 4 weeks after the treatment and one month after the last treatment session.
Method of measurement
Force plate
2
Description
Investigating spasticity by modified Ashworth questionnaire
Timepoint
Assessment of spasticity at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session.
Method of measurement
Modified Ashworth scale
3
Description
Assessment of gait by 12-item gait scale in multiple sclerosis (12-MSWS)
Timepoint
Assessment of walking at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session
Method of measurement
12-item walking scale in people with multiple sclerosis(12-MSWS)
4
Description
Assessment of neuromodulation by somatosensory evoked potentials
Timepoint
Evaluation of neuromodulation at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session.
Method of measurement
Somatosensory evoked potential apparatus
5
Description
Examining the level of fatigue using the modified MS fatigue questionnaire(MFIS)
Timepoint
Evaluation of fatigue at the beginning of the study (before the intervention), 4 weeks after the treatment and one month after the last treatment session
Method of measurement
Modified fatigue impact scale(MFIS)
Intervention groups
1
Description
Intervention group: Task-oriented training + anodal tDCS cerebellum and DLPFC
Category
Rehabilitation
2
Description
Intervention group: Task-oriented training + anodal tDCS cerebellum
Category
Rehabilitation
3
Description
Intervention group: DLPFC anodal tDCS
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Faezeh Abbaschian
Street address
No. 18, Azadeghan dead end, Ahmadian Ave, Torkamanestan St, Motahari St
City
Tehran
Province
Tehran
Postal code
1565915416
Phone
+98 21 8844 6048
Email
abbaschian@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No.18, Azadeghan deadend, Shahid Ahmadian Ave, Torkamanestan St, Motahari St
City
Tehran
Province
Tehran
Postal code
1565915416
Phone
+98 21 8844 6048
Email
abbaschian@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
Minoo khalkhali Zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
minoo_kh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo khalkhali zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
faezeh_abaschian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
minoo khalkhali zavieh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
faezeh_abaschian@yahoo.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