NCT07700537

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Jul 2025Jan 2027

Study Start

First participant enrolled

July 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 8, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

post-stroke aphasiasupplementary motor areatranscranial direct current stimulation

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

EXPERIMENTAL

PSA 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.

Other: transcranial direct current stimulation

The speech-language therapy group

NO INTERVENTION

The 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.

tDCS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

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.

Locations