Clinical Trial

Acupuncture + Neuromodulation for Post-Stroke Aphasia

Unknown
View on ClinicalTrials.gov →
Record status
This record was last updated July 10, 2024 (before its estimated October 2024 completion). Its status may not reflect the trial's current state.
Summary
The aim of this clinical trial is to assess the therapeutic efficacy of acupuncture combined with neuromodulation techniques for the treatment of post-stroke aphasia and to explore the brain mechanisms involved. The study seeks to answer two primary questions: the effectiveness of the integrated intervention of acupuncture and repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia, and the mechanisms underlying language function impairment and recovery. The research is divided into two parts: Part One: Participants will be randomized into two groups: Group A: Receives low-frequency rTMS followed by high-frequency rTMS. Group B: Receives high-frequency rTMS followed by low-frequency rTMS. Part Two: Participants will be randomized into four groups: rTMS Experimental Group: Individualized targets and intervention methods based on integrated fMRI and behavioral data. The rTMS intervention involves continuous treatment for two weeks, 5 sessions per week, each lasting 10-25 minutes, at 80% of the active motor threshold (AMT). rTMS Control Group: Standard rTMS protocol guided by clinical recommendations, with continuous treatment for two weeks, 5 sessions per week, each 20 minutes, at 80% AMT. Electroacupuncture Group: Points include Speech Area 1 (Yan Yu Yi Qu 1), Speech Area 2 (Yan Yu Yi Qu 2), Fengchi (Fengchi, GB20), Tiantu (Tiantu, CV22), Tongli (Tongli, HT5), Lianquan (Lianquan, CV23), and Paralianquan (Pang Lianquan). After needle insertion and obtaining Qi, electrical stimulation is applied with a discontinuous wave at 2Hz, at a tolerable intensity for the patient, for 30 minutes each session. Combined rTMS and Electroacupuncture Group: Combines both intervention methods as described above.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06493747
Lead Sponsor Shanghai Yueyang Integrated Medicine Hospital
Conditions Aphasia, Rehabilitation
Enrollment 82 participants
Start Date 2020-06-01
Primary Completion 2024-10 (estimated)
Study Completion 2025-01 (estimated)
Updated on ClinicalTrials.gov 2024-07-10