The study of transcranial direct current stimulation(tDCS) effect on recovery of the cognitive and linguistic abilities in Persian-Speaking patients with chronic Aphasia.
The aim of this research is to investigate the effects of transcranial direct current stimulation on improvement of severity of aphasia and executive function in patients with aphasia.
Design
This is a single-blind, sham-controlled crossover trial with sample size of 18 patients.
Settings and conduct
In the rehabilitation centers of Hamadan, Patients, randomly receive two types of real and sham stimulation. The participants were assessed for picture-naming and P-WAB-1.
Real-tDCS or Sham-tDCS (1 mA- 20 min) was administered for consecutive days followed by a 7-day rest period to avoid carry-over effect.
After each tentative condition, and at the end of each real or sham stimulation period, the accuracy and latency of picture-naming and P-WAB-1 were assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Aphasia due to a single left-hemispheric stroke at least 6 months prior to the investigation, age range in 30-80 years, pre-morbid right-handedness .
Exclusion criteria: People who have a history of seizer, dementia and psychiatric disorder. Patients who have global aphasia, sever visual or hearing deficits, severe apraxia of speech or oral apraxia, sever dysarthria. Patients who have a history of stroke more than once.
Intervention groups
The intervention and control group are the same. Subjects will be received 5 consecutive real stimulation sessions (20 min, 1mA), and 5 consecutive sham stimulation sessions. The order of conditions will be randomized across subjects.
Main outcome variables
Severity of aphasia; Executive function
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20160509027820N2
Registration date:2020-12-02, 1399/09/12
Registration timing:prospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Bahareh Rezaei
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
e.rezaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of transcranial direct current stimulation(tDCS) effect on recovery of the cognitive and linguistic abilities in Persian-Speaking patients with chronic Aphasia.
Public title
The study of tDCS effect on Aphasia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Aphasia due to stroke
More than 6 month from stroke onset
Age range in 30-80 years
Right-handedness
Left stroke
Exclusion criteria:
History of seizer, dementia, and neuro-psychological disorders
Sever visual or hearing sensory deficits
Sever Dysarthria
Moderate to sever oral or speech Apraxia
More than once stroke
Global Aphasia
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
. Subjects will be received 5 consecutive real stimulation sessions (20 min, 1mA), and 5 consecutive sham stimulation sessions. The order of conditions will be randomized across subjects, and the all of patients will be blinded to the type of tDCS.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice Chancellery for Research and Technology., Hamadan University of Medical Sciences., Shahid Fahmideh Ave., Hamadan.
City
Hamedan
Province
Hamadan
Postal code
6516705495
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.UMSHA.REC.1399.652
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.5
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
Primary outcomes
1
Description
Severity of Aphasia
Timepoint
Before intervention, Immediately and one week after intervention
Method of measurement
Score of Persian-Western Aphasia Battery -1 (P-WAB-1)
2
Description
Executive Function
Timepoint
Before intervention, Immediately and one week after intervention
Method of measurement
Score of Wisconsin Card Sorting Test (WCST)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Subjects will participate in 5 consecutive real tDCS sessions (20 min, 1mA). The active electrode (anode) and the reference electrode (cathode) is placed over left superior temporal gyrus (left-STG) and right supraorbital respectively.
Category
Rehabilitation
2
Description
Control group: Sham transcranial direct current stimulation; the active electrode (anode) and the reference electrode (cathode) is placed over left superior temporal gyrus (left-STG) and right supraorbital respectively. 1 mA current intensity only for the first 30 seconds, turned off current for remained 20 minutes stimulation time.