Acupuncture and neuromodulation for treating post-stroke aphasia

Efficacy and Mechanism Study of Acupuncture Combined With Neuromodulation Technology for Post-Stroke Aphasia Based on Multimodal Functional Magnetic Resonance Imaging

This study is testing if combining acupuncture with a brain stimulation technique can help people who have trouble speaking after a stroke.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06493747 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining acupuncture with neuromodulation techniques, specifically repetitive transcranial magnetic stimulation (rTMS), in treating post-stroke aphasia. Participants will be randomized into different groups to receive varying sequences of rTMS and acupuncture treatments over a two-week period. The study also seeks to understand the brain mechanisms involved in language recovery following stroke. By employing a randomized, blinded, controlled design, the trial aims to provide insights into innovative therapeutic strategies for aphasia rehabilitation.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 25 to 75 who have been diagnosed with aphasia following a first-time stroke in the left cerebral hemisphere.

Not a fit: Patients who have had multiple strokes or those with severe cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance language recovery in patients suffering from post-stroke aphasia.

How similar studies have performed: While some studies have explored the use of rTMS for aphasia, the combination with acupuncture represents a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with aphasia following stroke according to both traditional Chinese and Western medical standards; first-time stroke in the left cerebral hemisphere (including cerebral infarction and cerebral hemorrhage), with unilateral lesion.
2. Age between 25 and 75 years old, disease course of at least 1 month, no gender restrictions.
3. Right-handed as tested by the Edinburgh Handness Inventory, with at least an elementary school education level.
4. Retention of basic cognitive functions such as attention, memory, and visuospatial skills (Non-language-based Cognitive Assessment, NLCA score \>70).
5. Aphasia confirmed by initial assessment with the Western Aphasia Battery (WAB); an Aphasia Quotient (AQ) \<93.8 indicates aphasia.
6. Possess a certain level of auditory comprehension and can tolerate research examinations lasting 0.5-1 hour.
7. The subject and their legal guardian understand and consent to participate in this study and have jointly signed the informed consent form.

Exclusion Criteria:

1. Moderate to severe dysarthria as assessed by the Frenchay Dysarthria Assessment.
2. Severe speech apraxia or oral-facial apraxia.
3. Significant anxiety or moderate to severe depressive symptoms as assessed by the Hamilton Anxiety and Depression Scales.
4. Pre-stroke speech or language disorders.
5. Severe systemic diseases such as cardiopulmonary diseases that cannot tolerate rehabilitation treatment or infectious diseases.
6. Significant sleep disorders or mental disorders.
7. Pregnant or lactating women.
8. Contraindications for MRI examination (presence of metal foreign bodies or other implanted electronic devices in the body).

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Yueyang Integrated Medicine Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lei Chen, Ph.D.

Conditions: Aphasia, Rehabilitation