RecruitingNot ApplicableNCT07113990

Electroacupuncture and rTMS for Post-Stroke Motor Recovery

Efficacy and Safety of Electroacupuncture Combined With rTMS on Motor Function Recovery After Stroke: A Multi-center Randomized Controlled Clinical Study


Sponsor

Jing Tao

Enrollment

180 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria7

  • Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
  • 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 Criteria9

  • History of epilepsy or familial epilepsy.
  • 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.

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Interventions

PROCEDUREActive 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.

PROCEDURESham 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.

DEVICEActive 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.


Locations(3)

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

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NCT07113990


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