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Recruiting NCT07113990

Electroacupuncture and rTMS for Post-Stroke Motor Recovery

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active EA, Sham EA, Active rTMS.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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.
  • Procedure 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.
  • Device 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.

Primary outcome measures

  • Fugl-Meyer Assessment (FMA) [Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
Secondary outcome measures (4)
  • Arm Research Action Test (ARAT) [Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Functional Ambulation Classification (FAC) [Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Modified Barthel Index (MBI) [Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]
  • Stroke-Specific Quality of Life Scale (SS-QOL) [Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • Fuzhou University Affiliated Provincial Hospital — Fuzhou
  • Fujian Provincial People's Hospital — Fuzhou
  • Wenzhou Hospital of Traditional Chinese Medicine — Wenzhou

Identifiers

NCT: NCT07113990 · FujianUTCM-7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗