- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471570
Effect of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Right-hemisphere on Picture Naming in Chronic Aphasia
The Effect of tDCS Stimulation of Right Inferior Frontal Gyrus on Language Recovery in Speakers With Aphasia
There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy.
This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People with chronic aphasia following the stroke
Exclusion Criteria:
- history of seizure or epilepsy,
- previous adverse reactions to TMS/tDCS,
- having a pace-maker or a metal implanted in the brain
- being pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: anodal tDCS
20 minutes of one mA anodal High-Definition tDCS (HD-tDCS) over right IFG combined with 40 minutes of naming therapy for five consecutive days in week 1
|
The study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke.
Other Names:
|
Sham Comparator: sham tDCS
20-minutes sham HD-tDCS with 40-minutes therapy of naming therapy for five consecutive days in week 1
|
The study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Picture naming task
Time Frame: Immediately after the end of each treatment session and block
|
One hundred and sixty pictures of concrete nouns from the Snodgrass and Vanderwart (1980) picture set (colored version) were utilised to measure the percentage of object naming accuracy.
In particular, these pictures were divided into Set A (training targets) and Set B (untrained generalization targets), with eighty stimuli in each set.
|
Immediately after the end of each treatment session and block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
language task
Time Frame: Immediately after the end of each treatment block
|
* Overall language skills are measured through the overall aphasia scores provided by the Cantonese version of Western Aphasia Battery (short-form). The scale is called Aphasia quotient: Minimum value = 0, maximum value = 100, with higher scores mean a better performance. |
Immediately after the end of each treatment block
|
Cognitive task
Time Frame: Immediately after the end of each treatment block
|
The cognitive skills are measured through the subtest scores provided by Oxford Cognitive Screening-Cantonese.
The test uses different sub-tests including the Picture naming, Semantics, Orientation, Visual field task, Sentence reading , Calculation, Attention, Praxis, Memory, and Executive tasks.
The range of values varies across the subtests.
For all subtests except the executive task, the higher scores reflect better performance.
For executive tasks the lower scores reflect better performance.
|
Immediately after the end of each treatment block
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tDCSAphasia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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