Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2021-11-01
2024-10-31
Brief Summary
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Detailed Description
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This randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with Broca's Aphasia randomly assigned either to sham or an anodal tDCS groups. Following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. Simultaneously, the treatment group will receive 20 minutes of 2mA anodal HD-tDCS over the left IFG, while the sham group will receive the 30s of 2mA anodal HD-tDCS. Structural, resting state and task activated functional MRI will be performed. Data acquisition will be performed before, immediately after and two months after the treatment.
Repeated measure ANOVA for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tDCS. Pearson's correlation coefficient of left IFG and its homolog in the right hemisphere through Independent component analysis (ICA) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for IFG and other major languages hubs for oral language production between groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Real tDCS
Five post-stroke patients will be allocated by the flip the coin method to the experimental group. Participants will receive anodal tDCS stimulation for 20 minutes
Real tDCS
An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the left inferior frontal gyrus during speech therapy.
Sham tDCS
Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s
Sham tDCS
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.
Interventions
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Real tDCS
An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the left inferior frontal gyrus during speech therapy.
Sham tDCS
An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the left inferior frontal gyrus during speech therapy.
Eligibility Criteria
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Inclusion Criteria
2. Right handedness
3. Demonstrated features of Broca's Aphasia
4. Cantonese speaker
5. Comprehension sufficient to carry out tasks
6. No history of other neurological diseases
Exclusion Criteria
2. Bilateral or multiple brain lesions
3. Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders
4. Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos
5. Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures
6. Taking anti-depressant medications
18 Years
65 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr Min Wong
Assistant Professor
Principal Investigators
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Min Ney Wong, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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The Hong Kong Polytechnic University
Kowloon, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSEARS20220211001
Identifier Type: -
Identifier Source: org_study_id
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