Temporal interference stimulation for language recovery after stroke
Clinical Study on the Safety and Efficacy of Temporal Interference Stimulation in the Treatment of Post-Stroke Aphasia
This test will try temporal interference brain stimulation together with speech therapy to improve language in people with post-stroke aphasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07346378 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind study will enroll 40 patients with post-stroke aphasia and assign 20 to real temporal interference stimulation (TIS) and 20 to sham stimulation. The real TIS uses high-frequency pairs (about 1400 Hz and 1430 Hz) delivered for 30 minutes once daily over 10 consecutive days, and sessions are paired with standard speech and language therapy. Outcomes are changes from baseline on language batteries (Western Aphasia Battery and the Aphasia Battery of Chinese) measured after treatment and at follow-up, with patients and assessors blinded to allocation. The study is single-center at The First Affiliated Hospital of Anhui Medical University and includes right-handed, native Mandarin-speaking adults aged 18–80 with complete assessment and imaging data.
Who should consider this trial
Good fit: Ideal candidates are right-handed, native Mandarin-speaking adults aged 18–80 diagnosed with post-stroke aphasia who can complete imaging and language assessments and provide informed consent.
Not a fit: Patients with cerebellar stroke involvement, severe dysarthria, uncontrolled epilepsy, implanted pacemakers or deep-brain stimulators, prior brain resections, or other severe psychiatric disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a noninvasive way to boost language recovery after stroke when combined with speech therapy.
How similar studies have performed: Temporal interference stimulation is a relatively new technique with promising preclinical data but limited clinical evidence in aphasia, whereas more established noninvasive methods (e.g., TMS, tDCS) have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with post-stroke aphasia; * Right-handed; * Native Chinese speaker with comprehension of Mandarin; * Aged 18-80 years; * Complete relevant assessment and imaging data; * Informed consent obtained from the patient and their family. Exclusion Criteria: * Cerebellar involvement in the stroke lesion, and incomplete scanning of cerebellar structures; * Severe dysarthria; * Concurrent epilepsy with occasional seizures; * Implanted pacemaker or deep brain stimulator; * History of brain tissue resection for prior lesions such as brain tumours or brain abscesses; * Other severe psychiatric disorders.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Yuqian Zhan
- Email: zhanyuqian1998@163.com
- Phone: +86 133 3564 4731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.