A Clinical trial to evaluate the efficacy of Transcranial Direct Current Stimulations (TDCS) on movement and cognitive functions in patients with subacute brain ischemic stroke
The aim of this double-blind clinical trial study is to evaluate the efficacy of Transcranial Direct Current Stimulations (TDCS) on movement and cognitive functions in patients with subacute brain ischemic stroke. The target population will be 100 patients with subacute brain ischemic stroke who referred to the specialized clinic of Toloo in Rasht. Patients will be selected by a psychiatrist based on clinical interview. After signing the informed consent and considering inclusion and exclusion criteria, participants will enter the study by Convenience sampling. After sampling, the samples will be allocated to the control group, sham group and two intervention groups. The exclusion criteria will be defined by a history of epilepsy or patients unwillingness to participate in the study. Treatment will be carried out in fifteen sessions, four sessions per week, and a direct and continuous electrical stimulation to the brain cortex through electrodes for a maximum duration of thirty minutes. Treatment effectiveness will be assessed after 15 days, 1 month and 3 month later by using of National Institutes of Health Stroke Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070921965N7
Registration date:2017-08-04, 1396/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Homa Zarrabi
Name of organization / entity
Guilan University of Medical Sceinces,«Kavosh » Cognitive Behaviour Sciences and Addiction Researc
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
shafakavosh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-09, 1396/04/18
Expected recruitment end date
2017-11-09, 1396/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to evaluate the efficacy of Transcranial Direct Current Stimulations (TDCS) on movement and cognitive functions in patients with subacute brain ischemic stroke
Public title
A Clinical trial to evaluate the efficacy of Transcranial Direct Current Stimulations (TDCS) on movement and cognitive functions in patients with subacute brain ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with the brain stroke; people aged at least 21 years during 48 hours of their first brain stroke; Exclusion criteria: cardiac pacemaker or metal implants or instruments inside the patient’s body; treatment resistant seizures; using any psychoactive or stimulation drugs; pregnancy; the existence of any neurological condition affecting sensory-motor systems; such as brain tumors; dementia; or severe substance abuse and medications.
Age
From 21 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For elimination of the possibility of any probable bias due to the knowledge of patients and assessing physicians about the type of treatment we will perform a double blind study. Participants and the evaluating investigators (except the technician that applied TDCS) were blinded to the intervention type. After convenience sampling, the samples will be allocated to the control group, sham group and two intervention groups. The Block Randomization is used for random allocation. This means that patients who entered the study will be randomly assigned number.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Ethics committee of Guilan University of Medical Sciences,Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of Assistance Research and Technology, Rasht, Iran
City
Rasht
Postal code
4193893345
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
IR.GUMS.REC.1396.127
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
movement and cognitive functions
Timepoint
Treatment effectiveness will be assessed after 15 days, 1 month and 3 month later by using of National Institutes of Health Stroke Scale.
Method of measurement
National Institutes of Health Stroke Scale, REY Verbal Memory Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The treatment will be carried out in 15 sessions, three sessions per week and a consistent, direct and uniform current will be sent to the brain through anodal type waves for up to 30 minutes.
Category
Treatment - Other
2
Description
Intervention group2: The treatment will be carried out in 15 sessions, three sessions per week and a consistent, direct and uniform current will be sent to the brain through cathodal type waves for up to 30 minutes.
Category
Treatment - Other
3
Description
Sham Group: Sham group will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off.
Category
Treatment - Other
4
Description
Control group: Control group will not have an electrical stimulation (TDCS) of the brain.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooloo Specialty and subspecialty of psychiatry Clinic of Rasht
Full name of responsible person
Dr kiomars Najafi
Street address
Tooloo Specialty and Subspecialty of Psychiatry Clinic ,Shabnam alley, Golsar Crossroads, Opposite to the Municipal of Area (3),Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr kiomars Najafi
Street address
Guilan University of Medical Sciences,15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3366 6268
Fax
Email
kkiomars@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3366 6268
Fax
Email
kkiomars@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Mona Musaie
Position
Master Of science in Psychology
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,15 Kordad Avenue, Shafa Hospital, Rasht, Iran Rasht Rasht Guilan
City
Rasht
Postal code
Phone
Fax
Email
monamusaie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)