- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347327
The Effect of Dual-target tACS Combined With Speech Training on Repetition Disorder After Stroke
This clinical trial aims to study whether dual-target transcranial alternating current stimulation (tACS) applied to the auditory and motor brain region can improve repetition disorder in people with stroke, and to evaluate the safety of tACS. The main goals are to answer the following questions:
- Can dual-tACS stimulation of the auditory and motor brain area improve repetition functions in people with aphasia after stroke?
- Can it improve the integration of auditory information and speech motor control during communication?
Researchers will compare the effects of real tACS versus sham (placebo) stimulation to see if real stimulation leads to better outcomes in aphasia patients.
Participants will:
- Receive one extra 20-minute session of either real or sham tACS each day for 10 days
- Attend clinic visits before and after 10-days stimulation for clinical assessments(WAB) and fNIRS recording related brain activity
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
- Age ranging from 30 to 80 years old;
- Native language is Mandarin or Cantonese;
- Right-handed;
- Diagnosed with aphasia by the Western Aphasia Battery (WAB) scale;
- Able to cooperate in completing the speech repetition test;
- Normal hearing.
Exclusion Criteria:
- Currently receiving non-invasive brain stimulation treatment;
- Lesions involving the Broca or STG brain regions;
- History of epilepsy, mental illness,or other neurological or mental disorders;
- Any contraindications for transcranial electrical stimulation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: real group
dual-target tACS on auditory and motor brain area at a frequency of 8 Hz,with individualized current intensity, delivered for 20 minutes.
|
speech training(especially repetition training) synchronized with tACS stimulation
dual-target tACS on auditory and motor brain area at a frequency of 8 Hz,with individualized current intensity, delivered for 20 minutes.
|
|
Sham Comparator: sham group
sham tACS except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in real group.
|
speech training(especially repetition training) synchronized with tACS stimulation
except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in real group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Aphasia Battery (WAB) score
Time Frame: Baseline and 10-days
|
Western Aphasia Battery (WAB) score:0-100,higher score means better language function
|
Baseline and 10-days
|
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
- Nos.82102648
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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