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NCT Number: NCT07113990

Electroacupuncture and rTMS for Post-Stroke Motor Recovery

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Provincial People's Hospital, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    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.

Secondary outcomes

  1. Arm Research Action Test (ARAT)

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    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.

  2. Functional Ambulation Classification (FAC)

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    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.

  3. Modified Barthel Index (MBI)

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    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.

  4. Stroke-Specific Quality of Life Scale (SS-QOL)

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    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.

Other outcomes

  1. Kinematic Analysis of Upper Limb Motor Tasks

    Time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up

    Optical motion capture of limb movement kinematics during functional tasks

  2. Blood Biomarkers

    Time frame: Baseline, 2 weeks post-intervention

    Circulating neuroplasticity and inflammation biomarkers in venous blood samples.

  3. Electrophysiological Assessments (EMG, EEG, TMS)

    Time frame: Baseline, 2 weeks post-intervention

    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.

  4. fMRI

    Time frame: Baseline, 2 weeks post-intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Tao, PhD

CONTACT

[email protected]

(+86)0591-22861227

Qingping Su, MD

CONTACT

（+86）15280409492

Sponsors and collaborators

Lead sponsor

Jing Tao

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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