Electroacupuncture and rTMS for Post-Stroke Motor Recovery
NCT ID: NCT07113990
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-08-27
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS + Active EA group
Active EA
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.
Active rTMS
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.
Active rTMS + Sham EA group
Sham EA
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.
Active rTMS
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.
Interventions
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Active EA
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.
Sham EA
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.
Active rTMS
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.
Eligibility Criteria
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Inclusion Criteria
* First-ever stroke, unilateral hemispheric lesion, related to motor dysfunction.
* Age between 40 and 75 years.
* Duration from stroke onset between 2 weeks and 6 months.
* Brunnstrom stage II-IV.
* Right-handed.
* Able to understand instructions and voluntarily provide written informed consent.
Exclusion Criteria
* Motor dysfunction due to non-vascular causes (e.g., tumor, trauma).
* Severe aphasia or cognitive impairment (MoCA \< 18).
* Severe systemic complications (e.g., severe organ dysfunction, deep vein thrombosis).
* Presence of metallic implants or contraindications for MRI.
* Severe anxiety (HAMA \> 7) or depression (HAMD \> 8).
* Severe spasticity (modified Ashworth ≥ 2).
* Fear or intolerance of TMS or electroacupuncture.
* Pregnancy, breastfeeding, or concurrent participation in other clinical trials affecting outcomes.
40 Years
75 Years
ALL
No
Sponsors
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Jing Tao
OTHER
Responsible Party
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Jing Tao
Professor
Locations
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Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China
Fujian Provincial People's Hospital
Fuzhou, Fujian, China
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Qingping Su, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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FujianUTCM-7
Identifier Type: -
Identifier Source: org_study_id
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