This study will be designed as a double_blind clinical trial to assess the efficacy of brain Stimulation therapy on depression after stroke. Sample size consists of is 150 patients with stroke who referred to the specialized clinic of Toloo in Rasht. Patients are selected by a psychiatrist based on clinical interview according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5). After signing the informed consent and considering inclusion and exclusion criteria, Patients with stroke will enter the study by Convenience sampling. After sampling, the samples will be allocated to the control group and two intervention groups. 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, three sessions per week, and a direct and continuous electrical stimulation will be sent the cortex through electrodes for a maximum duration of thirty minutes. Treatment effectiveness will be assessed on 15 days, 1 month 3 month later according to Beck depression questionnaire, second edition.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017030921965N4
Registration date:2017-05-28, 1396/03/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
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
2017-03-09, 1395/12/19
Expected recruitment end date
2017-07-10, 1396/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the efficacy of electrical stimulation of the brain with direct electrical current on depression after stroke
Public title
Clinical trial to evaluate the efficacy of electrical stimulation of the brain with direct electrical current on depression after 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 and Severe cognitive declines.
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:
150
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 randomly entered into intervention and control groups. The sealed envelope is used for random allocation.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
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
2016-11-12, 1395/08/22
Ethics committee reference number
IR.GUMS.REC.1395.273
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
Treatment effectiveness will be assessed on 15 days, 1 month and 3 month later.
Method of measurement
Beck Depression questionnaire
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
Control group: The control group will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off.
Category
Treatment - Other
3
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
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
Shabnam alley, Golsar Crossroads, Opposite to the Municipal of Area (3),Rasht, Iran