Investigation on the clinical efficacy of transcranial direct current stimulation (tDCS) combined with traditional dysphagia therapy for treatment of dysphagia in patients with Multiple Sclerosis: A randomized, double-blind, sham-controlled, clinical trial
Investigation on the clinical efficacy of transcranial direct current stimulation combined with traditional dysphagia therapy (TDT) for treatment of dysphagia in patients with Multiple Sclerosis
Design
Two arm parallel group randomized trial with blinded, sham controlled clinical trial with a parallel group design of 40 patients.Randomisation is carried out using excel software.
Settings and conduct
Study is performed on the MS patients that are refereed to kashani hospital in Isfahan city. principal researcher, the person in charge of data collecting, the person in charge of data analyzing as well as participants are blinded relative to real or sham intervention.
Participants/Inclusion and exclusion criteria
Diagnosis of multiple sclerosis based on the McDonald criteria
range of age between 20 and 60 years
presence of dysphagia
Intervention groups
(1) MS patients receiving real brain stimulation
(2) MS patients receiving sham brain stimulation
Main outcome variables
Swallowing ability
Severity of MS disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150220021150N1
Registration date:2022-09-19, 1401/06/28
Registration timing:prospective
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
meysam amidfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 1118
Email address
amidfar-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the clinical efficacy of transcranial direct current stimulation (tDCS) combined with traditional dysphagia therapy for treatment of dysphagia in patients with Multiple Sclerosis: A randomized, double-blind, sham-controlled, clinical trial
Public title
Effect of transcranial direct current stimulation in treatment of dysphagia in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS based on McDonald criteria
Range of age between 20 and 60
Presence of dysphagia
The block randomization is used in this study . In this clinical trial, the size of block is 6, including 3 participants in intervention group and 3 participants in control group. The Allocation concealment is used for concealment. The Random allocation software and coded containers are used as randomization tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, principal researcher, the person in charge of data collecting and persons in charge of analyzing of data are blind related to real tDCS or sham tDCS.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.ARI.MUI.REC.1401.168
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
Swallowing ability
Timepoint
Before intervention , immediately after intervention and one month after intervention
Method of measurement
Dysphagia in Multiple Sclerosis Questionnaire
Secondary outcomes
1
Description
Severity of disease
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Expanded Disability Status Scale
Intervention groups
1
Description
Intervention group: MS patients receiving active brain stimulation
Category
Rehabilitation
2
Description
Control group: MS patients receiving sham brain stimulation
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Fereshte Ashtari
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3131
Fax
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fereshte Ashtari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
f_ashtari@med.mui.ac.ir
Web page address
https://med.mui.ac.ir/node/1972
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fereshte Ashtari
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3131
Email
f_ashtari@med.mui.ac.ir
Web page address
https://med.mui.ac.ir/node/1972
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Meysam Amidfar
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81839-83434
Phone
+98 31 3233 0091
Email
amidfar.m@gmail.com
Web page address
https://inrc.mui.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD