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Electroacupuncture and rTMS for Post-Stroke Motor Recovery

J

Jing Tao

Status

Enrolling

Conditions

Stroke

Treatments

Device: Active rTMS
Procedure: Active EA
Procedure: Sham EA

Study type

Interventional

Funder types

Other

Identifiers

NCT07113990
FujianUTCM-7

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups

Active rTMS + Active EA group
Experimental group
Treatment:
Procedure: Active EA
Device: Active rTMS
Active rTMS + Sham EA group
Sham Comparator group
Treatment:
Procedure: Sham EA
Device: Active rTMS

Trial contacts and locations

3

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Central trial contact

Qingping Su, MD; Jing Tao, PhD

Data sourced from clinicaltrials.gov

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