Efficacy and Neural Mechanisms of Transcranial Direct Current Stimulation Targeting the Supplementary Motor Area for the Treatment of Subacute Post-stroke Aphasia
Study on the Efficacy and Neural Mechanisms of Transcranial Direct Current Stimulation Targeting the Supplementary Motor Area for the Treatment of Subacute Post-stroke Aphasia
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) in patients with post-stroke aphasia (PSA) and to explore its potential neural mechanisms. The study will recruit PSA patients and provide them with 14 tDCS sessions over 7 days, along with speech therapy. Language Behavior Scale scores and resting-state functional MRI scans will be collected before and after the intervention. In addition, a retrospective comparison will be conducted of language function and resting-state fMRI changes in a group of PSA patients who received only speech therapy; these patients did not undergo any physical intervention but received only speech therapy. Changes in Language Behavior Scale scores and functional connectivity (FC) before and after treatment in the speech therapy-only group will be analyzed and compared with those in the tDCS intervention group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2025
CompletedFirst Submitted
Initial submission to the registry
July 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 17, 2026
July 1, 2026
1.4 years
July 8, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aphasia quotient (AQ)
The Aphasia Battery of Chinese (ABC) is a standardized Chinese adaptation of the Western Aphasia Battery (WAB). The Aphasia Quotient (AQ) is a composite score that reflects the overall severity of language impairment. The AQ score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better language function (i.e., less severe impairment).
Baseline, immediately after all interventions have ended
Secondary Outcomes (1)
rs-fMRI
Baseline, immediately after all interventions have ended
Study Arms (2)
tDCS group
EXPERIMENTALPSA patients enrolled in the tDCS group received tDCS treatment twice daily for 7 consecutive days, along with 7 days of speech-language therapy. The current intensity was 2 mA, and each treatment session lasted 20 minutes.
The speech-language therapy group
NO INTERVENTIONThe speech-language therapy group received only 7 days of speech-language therapy.
Interventions
As a non-invasive brain stimulation technique, tDCS offers advantages such as convenience, safety, and low cost. Its mechanism of action involves regulating neuronal activity in the brain by applying a weak direct current to the scalp.
Eligibility Criteria
You may qualify if:
- Patients must be between 18 and 80 years of age
- First stroke in the left hemisphere
- Stroke onset within the past 12 weeks
- Native Chinese speakers who were able to communicate normally prior to onset
- Diagnosed with aphasia using the ABC scale
- Right-handed
- Informed consent obtained from the patient and family members
You may not qualify if:
- Time since stroke onset exceeds 12 weeks
- History of psychiatric or neurological disorders
- History of surgery for severe head trauma, brain tumors, or brain abscesses
- Severe articulation disorders
- Claustrophobia or implants incompatible with MRI
- Inability to cooperate with language scale testing or fMRI scanning
- History of previous stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
transcranial direct current stimulation (tDCS)
Hefei, Anhui, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University
Study Record Dates
First Submitted
July 8, 2026
First Posted
July 14, 2026
Study Start
July 30, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with other researchers due to patient privacy protection and the limitations of the informed consent form.