Comparison of the effectiveness of transcranial direct current stimulation with galantamine and fluoxetine in the treatment of aphasia after stroke
Design
Randomized, clinical trial phase 3, single center, crossover and
double blind with a sample size of 16 patients.
Settings and conduct
In the mobasher kashani rehabilitation center, all patients will use drug intervention with galantamine 16 mg per day and fluoxetine 20 mg per day for 12 weeks. After the drug intervention and after 2 weeks of washing out period, real and placebo tDCS interventions will be applied for five consecutive days.
The patients' aphasia will be assessed before and after the drug intervention, before and after two type of tDCS
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stroke patients aged 36 to 75 years; individuals with no history of neurological diseases, epilepsy, dementia, or psychiatric disorders; Individuals with damage to the left hemisphere of the brain, without having a lesion in the right hemisphere; aphasia following a stroke, with at least six months since its onset. Exclusion criteria: Individuals with poor general health; individuals allergic to galantamine and fluoxetine.
Intervention groups
Intervention group: Drug intervention with galantamine 16 mg per day and fluoxetine 20 mg per day for 12 weeks. After the drug intervention, transcranial direct current stimulation (tDCS) will be applied to the left superior temporal gyrus with a current of 1 mA for 20 minutes over five consecutive days. Control group: Drug intervention with galantamine 16 mg per day and fluoxetine 20 mg per day for 12 weeks. After the drug intervention, placebo tDCS will be applied to the left superior temporal gyrus with a current of 1 mA for 20 minutes over five consecutive days.
Main outcome variables
Severity of aphasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250130064571N1
Registration date:2025-03-06, 1403/12/16
Registration timing:registered_while_recruiting
Last update:2025-03-06, 1403/12/16
Update count:0
Registration date
2025-03-06, 1403/12/16
Registrant information
Name
Ailin Talimkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 1857
Email address
m.talimkhani@edu.umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-18, 1403/10/29
Expected recruitment end date
2025-06-19, 1404/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Transcranial Direct Current Stimulation and Galantamine and Fluoxetine on Aphasia after Stroke
Public title
Evaluating the Effectiveness of Brain Stimulation and Medications for Post-Stroke Aphasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of stroke should be based on clinical and radiological criteria
Aphasia following a stroke that has occurred at least six months ago
Individuals who consent to participate in the study
Individuals who have no serious memory deficits
Exclusion criteria:
Individuals who are in poor general condition
Individuals who are allergic to galantamine and fluoxetine
Individuals who do not wish to continue participating in the study
Age
From 36 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
The method of grouping is a consecutive random assignment
by block; the block randomization method is carried out by a
computer-generated random number list; Statistical
software is designed to randomize subjects into
experimental and control groups by an independent
researcher; Allocation ratio is 1:1 using random block
sizes of 2; Allocation sequence is concealed from
researcher enrolling and assessing participants
sequentially numbered.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator of aphasia domains, the clinical caregiver, the data analyst, and all study participants did not know whether the brain stimulation applied to the targeted brain area of the patients was real or a placebo.
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
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2025-01-18, 1403/10/29
Ethics committee reference number
IR.UMSHA.REC.1403.760
Health conditions studied
1
Description of health condition studied
Aphasia after stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Aphasia score in the Persian WAB (P-WAB-1) questionnaire
Timepoint
Assessment of aphasia score at the beginning of the study (before starting the intervention), 3 months after using galantamine and fluoxetine, immediately after completing the real or sham brain stimulation
Method of measurement
Persian diagnostic aphasia battery bedside version (P-WAB-1)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Drug intervention with galantamine 16 mg per day and fluoxetine 20 mg per day for 12 weeks. After the drug intervention, transcranial direct current stimulation (tDCS) will be applied to the left superior temporal gyrus with a current of 1 mA for 20 minutes over five consecutive days.
Category
Rehabilitation
2
Description
Control group: Drug intervention with galantamine 16 mg per day and fluoxetine 20 mg per day for 12 weeks. After the drug intervention, placebo transcranial direct current stimulation (tDCS) will be applied to the left superior temporal gyrus with a current of 1 mA for 20 minutes over five consecutive days.