The effect of transcranial direct current stimulation on cognition in people with multiple sclerosis in three groups before and after the intervention.
Design
Clinical trial with one intervention group and 2 control groups with factorial groups, randomized, on 36 patients.
Settings and conduct
Place: Rofeideh hospital in Tehran.
Subjects were randomly divided into three groups of intervention, control one and control two. Cognitive Rehabilitation Program in addition to tDCS for intervention group, rehabilitation programin addition to shame tDCS was for Control Group one and just rehabilitation program for Control Group Two. The evaluator will be blind to the groups.
Participants/Inclusion and exclusion criteria
People between the ages of 20 and 50 years old who have received a definitive diagnosis of MS from a specialist and have no history of other comorbid psychological and neurological diseases.
Intervention groups
Cognitive rehabilitation program (including routine rehabilitation exercises in occupational therapy clinics) in addition to tDCS (application of 20 minutes of 2 mA current through the anode electrode on the scalp to the prefrontal dorsolateral region and the cathode electrode above the right eyebrow) presented on the intervention group. In the control group 1, shame tDCS is used (placing anode and cathode electrodes on the scalp for 20 minutes, establishing a current of 2 mA for 10 seconds and then cutting off the current for the next 10 seconds) with a rehabilitation program and in Control group 2 only runs the rehabilitation program.
Main outcome variables
Attention, working memory and information processing speed in people with MS
General information
Reason for update
Acronym
tDCS, MS
IRCT registration information
IRCT registration number:IRCT20210819052231N1
Registration date:2022-04-04, 1401/01/15
Registration timing:prospective
Last update:2022-04-04, 1401/01/15
Update count:0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Hamide Aghachavoshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7730 3532
Email address
hm.aghachavoshi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcranial direct current stimulation(tDCS) on attention, working memory and information processing speed in people with MS
Public title
The effect of transcranial direct current stimulation (tDCS) on cognition in people with MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in research
Have a definitive diagnosis of MS by a specialist doctor
EDSS score should be from 1 to 6
The person has no history of dementia and other psychotic illnesses
There is no Recurrence of relapsing while doing the study
Do not take corticosteroids for 28 days before the intervention
Have no history of other neurological diseases
Exclusion criteria:
Do not complete the intervention
Recurrence of relapsing occurs during the intervention
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting all samples for dividing them into groups as intervention experimental, control 1 and control 2 we will use the SAS application and the PROC SURVEYSELECT process, which is for generating a random sequence for experiments with more complex designs, including factorial experiments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, outcome assessors and data analysts will be unaware of how people are grouped.
Placebo
Used
Assignment
Factorial
Other design features
In this study, three groups will be examined. A group called the intervention group will receive the intervention along with tDCS. The control group one will receive intended intervention with sham tDCS. Control group two will only receive the intervention without any stimulation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation
Street address
University of Rehabilitation Sciences and Socia Health, Koodkiar St., Daneshjoo Blvd., Evin,
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-02-19, 1400/11/30
Ethics committee reference number
IR.USWR.REC.1400.303
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Score obtained for attention in the Paired Associate Learning test
Timepoint
Measurement of attention at the beginning of the study and after three weeks and 2 months after the intervention
Method of measurement
Paired Associate Learning test
2
Description
Score obtained for working memory in the Spatial Span test
Timepoint
Measurement of working memory at the beginning of the study and after three weeks and 2 months after the intervention
Method of measurement
Spatial Span test
3
Description
Score obtained for data processing speed in Paced Auditory Serial Addition Test
Timepoint
Measurement of information processing speed at the beginning of the study and after three weeks and 2 months after the intervention
Method of measurement
Paced Auditory Serial Addition Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group first: Cognitive rehabilitation program (including routine rehabilitation exercises in occupational therapy clinics) in addition to tDCS stimulation (20 minutes of two milliampere current applied through the anode electrode on the scalp of the prefrontal dorsultral region and the cathode electrode upper of right eyebrow ) 4 times a week for three weeks. The duration of each session will be 45 minutes.
Category
Rehabilitation
2
Description
Intervention group second: The tDCS is used artificially (placing the anode and cathode electrodes on the scalp for 20 minutes, establishing a 2 mA current for 10 seconds, and then cutting off the current for the next 10 seconds) with a cognitive rehabilitation program. 4 times a week for three weeks and the duration of each session will be 45 minutes.
Category
Rehabilitation
3
Description
Control group: Only the cognitive rehabilitation program runs. They will receive 4 times a week for three weeks and the duration of each session will be 45 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeideh hospital
Full name of responsible person
Nazila Akbarfahimi
Street address
Shahid Nemati St, south Salimi Ave., Anarzgoo Blv., Gheitariyeh
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Email
rofeideh.hospital@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoud Fallahi Khoshknab
Street address
Koodakyar, Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
webmaster@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamide Aghachavoshi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7730 3532
Fax
Email
hm.aghachavoshi@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamide Aghachavoshi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7730 3532
Fax
Email
hm.aghachavoshi@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamide Aghachavoshi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7730 3532
Fax
Email
hm.aghachavoshi@uswr.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
Not applicable
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 unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All individuals, including researchers working in academic and scientific institutions and those working in the clinic, can apply for the data.
Under which criteria data/document could be used
The data will be provided to researchers for further studies or to use this data for related research.
From where data/document is obtainable
Hamideh Aghachavoshi
Email Address: aghachavoshi_hamide@yahoo.com
Address: Unit 4, Block 33/2, Eram Dead End, Besharat St., Hakimieh, Tehran
Phone: 09137729652
Dr. Hojjatullah Haghgoo
Email Address: H.haghgoo@yahoo.com
Address: Department of Occupational Therapy, University of Rehabilitation and Social Health, Koodakiar St., Daneshjoo Blvd., Evin, Tehran
Phone: 02122180063
What processes are involved for a request to access data/document
Files and documents will be provided to the applicant through correspondence and application to the Department of Occupational Therapy of the University of Rehabilitation Sciences and Social Welfare and the approval of the director and deputy director of the Department of Occupational Therapy.