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This study aims to evaluate the combined efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and Electroacupuncture (EA) in improving motor function recovery post-stroke, compared to rTMS combined with sham EA. Participants will receive either active EA or sham EA alongside standard rTMS treatment. Outcomes will be assessed using standardized clinical scales and neuroimaging techniques to explore underlying neuroplasticity mechanisms.
Motor impairment is a major cause of disability following stroke, with central and peripheral neuromodulation strategies showing potential for functional recovery. Repetitive transcranial magnetic stimulation (rTMS) has been shown to promote neuroplasticity and enhance cortical excitability. Electroacupuncture (EA), by increasing somatosensory input, may further strengthen sensorimotor integration and cortical remodeling. However, limited clinical trials have systematically evaluated the synergistic effect of rTMS combined with EA.
This multi-center randomized controlled clinical study aims to assess the efficacy of combining rTMS and EA in improving motor function post-stroke. Outcome measures include clinical scales (FMA, ARAT, FAC), kinematic parameters, electrophysiological indices (EEG, EMG, TMS), blood biomarkers, and resting-state fMRI. The study is designed to explore central-peripheral neuroplasticity mechanisms and provide evidence for integrated rehabilitation approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS + Active EA group | Experimental |
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| Active rTMS + Sham EA group | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active EA | Procedure | Participants will receive electroacupuncture once daily for 2 consecutive weeks (total 10 sessions). Disposable sterile needles will be inserted at standardized acupoints to achieve de qi, then connected to an electroacupuncture device for 30 minutes per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) | The Fugl-Meyer Assessment is used for rating motor function recovery after stroke. Scores range from 0 to 100, with higher scores indicating better motor performance. | Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Arm Research Action Test (ARAT) | The Arm Research Action Test is used for assessing upper limb motor function across grasp, grip, pinch, and gross movement domains. Scores range from 0 to 57, with higher scores indicating better upper limb function. | Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic Analysis of Upper Limb Motor Tasks | Optical motion capture of limb movement kinematics during functional tasks | Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
| Blood Biomarkers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Tao, PhD | Contact | (+86)0591-22861227 | taojing01@fjtcm.edu.cn | |
| Qingping Su, MD | Contact | （+86）15280409492 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou University Affiliated Provincial Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham EA | Procedure | Participants will receive sham electroacupuncture once daily for 2 consecutive weeks (total 10 sessions). Disposable blunt needles will be placed at the same acupoints without skin penetration or electrical stimulation, with the electroacupuncture device turned on but delivering no current, for 30 minutes per session. |
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| Active rTMS | Device | Participants will receive high-frequency rTMS to the ipsilesional M1 area once daily for 2 consecutive weeks (total 10 sessions). Stimulation will be delivered with a MagPro R30 stimulator at 10 Hz, 1600 pulses per session, 4-second trains with 41-second inter-train intervals. |
|
| Functional Ambulation Classification (FAC) |
The Functional Ambulation Classification is used for evaluating the degree of ambulation independence. Scores range from 0 to 5, with higher scores indicating greater ambulation capability. |
| Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
| Modified Barthel Index (MBI) | The Modified Barthel Index is used for rating the level of independence in daily living activities. Scores range from 0 to 100, with higher scores indicating better functional independence. | Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
| Stroke-Specific Quality of Life Scale (SS-QOL) | The Stroke-Specific Quality of Life Scale is used for assessing health-related quality of life across 12 domains. Scores range from 49 to 245, with higher scores indicating better perceived quality of life. | Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up |
Circulating neuroplasticity and inflammation biomarkers in venous blood samples.
| Baseline, 2 weeks post-intervention |
| Electrophysiological Assessments (EMG, EEG, TMS) | Electromyography (EMG), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) assessments. Note: This outcome is planned to be conducted at selected sites depending on equipment availability and final coordination. The specific evaluation sites are under discussion. | Baseline, 2 weeks post-intervention |
| fMRI | Structural and functional MRI acquired on a 3 T scanner. Note: This outcome will be assessed only at Fujian Provincial Hospital (Affiliated Hospital of Fuzhou University). | Baseline, 2 weeks post-intervention |
| Fujian Provincial People's Hospital | Not yet recruiting | Fuzhou | Fujian | 350004 | China |
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| Wenzhou Hospital of Traditional Chinese Medicine | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |