Comparison of the effects of rTMS and tDCS combined with postural exercises on balance, postural stability and level of fear of falling in patients with Multiple sclerosis: a double-blind randomized controlled trial
Comparison of the effects of rTMS and tDCS combined with postural exercises on balance, postural stability, and level of fear of falling in patients with Multiple sclerosis
Design
A randomized, double-blinded, sham-controlled clinical trial with a parallel-group design of 60 patients. Block randomization using Random
allocation software is performed with Sealed envelopes.
Settings and conduct
The study is conducted in the Research Centre of Neuromuscular
Rehabilitation of Semnan University of Medical Sciences (Iran).
All participants are blind to the sham and active applications of the rTMS and tDCS.
All outcome measures are taken before and after the intervention by a blinded physiotherapist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age > 20 and <65 years; disability between 4.5 and 6.5 on the Expanded Disability Status Scale (EDSS); walking ability according to the EDSS score; a minimal leg spasticity score ≤ 1 on the Modified Ashworth spasticity scale; exclusion criteria: Pregnant women; neurological, orthopedic, and severe cardiac comorbidities; peripheral vestibular disorders (i.e., positional paroxysmal vertigo, Meniere’s disease, and acoustic neuroma); blindness in one or both eyes; exacerbation in the past 2 months or during the study.
Intervention groups
Three groups: cerebellar rTMS with postural training, cerebellar tDCS with postural training, sham rTMS, and tDCS with postural training.
Main outcome variables
The Berg Balance Score (BBS) and the stability indices at both static and dynamic levels of the Biodex Balance System are evaluated before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210905052374N1
Registration date:2021-11-14, 1400/08/23
Registration timing:prospective
Last update:2021-11-14, 1400/08/23
Update count:0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Mostafa Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
rahimim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of rTMS and tDCS combined with postural exercises on balance, postural stability and level of fear of falling in patients with Multiple sclerosis: a double-blind randomized controlled trial
Public title
Effects of rTMS and tDCS in balance of MS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically definite MS
Age > 20 and <65 years
Disability between 4.5 and 6.5 on the Expanded Disability Status Scale (EDSS)
Walking ability according to the EDSS score
A minimal leg spasticity score ≤ 1 on the Modified Ashworth spasticity scale
Exclusion criteria:
Pregnant women
Neurological, orthopedic and severe cardiac comorbidities
Peripheral vestibular disorders (i.e., positional paroxysmal vertigo, Meniere’s disease, and acoustic neuroma)
Blindness in one or both eyes
Exacerbation in the past 2 months
Exacerbation during the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the Block randomization method of the Restricted randomization method. Block randomization will be done by using Random allocation software and sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants are blind to the sham and active applications of the rTMS and tDCS.
All outcome measures are taken before and after the intervention by a blinded physiotherapist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
District 12, Enghelab St, Pich-e-Shemiran. Tehran University of Medical Sciences - School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
11489-65111
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.TUMS.FNM.REC.1400.107
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The stability indices at both static and dynamic levels of the Biodex Balance System
Timepoint
Before and after the intervention
Method of measurement
The Biodex Balance System (302-950 model, Biodex Medical Systems, Inc., New York, USA)
Secondary outcomes
1
Description
The Berg Balance Scale Score
Timepoint
Before and after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Participants in intervention group 1(cerebellar rTMS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. Participants in intervention group 2 (cerebellar tDCS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. In the sham rTMS and tDCS group (sham rTMS, and tDCS with postural training), participants receive only 30 s of stimulation at the beginning of a postural training session.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Centre of Semnan University of Medical Sciences
Full name of responsible person
Mostafa Rahimi
Street address
District 12, Enghelab St, Pich-e-Shemiran. Tehran University of Medical Sciences - School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 5132
Email
rahimim@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Quds Street, Keshavarz Blvd, Central University Organization, sixth floor
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
District 12, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
Email
rahimim@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
District 12, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
Email
rahimim@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
District 12, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
Email
rahimim@sina.tums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
Anyone interested can access the data.
Under which criteria data/document could be used
Any kind of analysis is allowed, provided that if the information is used somewhere, the source will be mentioned.