NCT06493747

Acupuncture + Neuromodulation for Post-Stroke Aphasia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Aphasia is a severe disabling consequence of stroke, typically caused by damage to the cortical and subcortical structures perfused by the left middle cerebral artery. Studies have indicated that over 20% of stroke patients develop aphasia. Although most patients exhibit some degree of spontaneous recovery within the first month after stroke, a significant number still suffer from chronic deficits six months post-stroke. Conventional rehabilitation methods and traditional Chinese medicine techniques often encounter efficacy plateaus in the treatment process. Therefore, there is an urgent need for innovative language therapy strategies to maximize recovery from aphasia. Non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), have the potential to modulate cortical excitability and plasticity. Acupuncture therapy can activate language neural functions, establish collateral cerebral vascular circulation, and reconstruct the neural circuitry of language motor control. However, when facing patients with complex post-stroke aphasia, there are certain limitations. This study employs a randomized, blinded, controlled clinical design to verify the therapeutic efficacy of acupuncture combined with transcranial magnetic stimulation in treating post-stroke aphasia and to explore the underlying brain mechanisms of 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

Type	Name	Description
DEVICE	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.
DEVICE	Combined High- and Low-Frequency rTMS Intervention	Similar to Arm A, but the sequence of low and high-frequency rTMS is reversed.
DEVICE	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.
DEVICE	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.
DEVICE	rTMS	Participants receive a conventional rTMS treatment as per established guidelines, serving as an active comparator to the experimental interventions.
DEVICE	Acupuncture	Participants receive "Kaiqiao Jieyan" acupuncture therapy alone, without rTMS, following traditional Chinese medicine protocols for post-stroke aphasia rehabilitation.

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2024-07-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: China