Acupuncture + Neuromodulation for Post-Stroke Aphasia

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.

Conditions

• Aphasia, Rehabilitation

Interventions

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Combined Low- and High-Frequency rTMS Intervention

This intervention involves the application of rTMS using an 8-shaped coil with a frequency of 1Hz for low-frequency stimulation and 5Hz for high-frequency stimulation, in accordance with the study protocol.

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Combined High- and Low-Frequency rTMS Intervention

Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.

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rTMS

Participants receive an individualized rTMS therapy plan based on integrated analysis of assessment data, targeting specific brain areas to enhance language function recovery post-stroke.

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rTMS + Acupuncture

Participants undergo a combined treatment of rTMS as described for the rTMS Experimental Group and traditional Chinese acupuncture based on the "Kaiqiao Jieyan" method, targeting specific acupoints to facilitate recovery.

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rTMS

Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.

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Acupuncture

Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2024-10-31

Completion

2025-01-31

Countries

• China

Study Locations