Electroacupuncture and rTMS for Post-Stroke Motor Recovery

NCT ID: NCT07113990

Last Updated: 2025-09-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active rTMS + Active EA group

Group Type EXPERIMENTAL

Active EA

Intervention Type 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.

Active rTMS

Intervention Type 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.

Active rTMS + Sham EA group

Group Type SHAM_COMPARATOR

Sham EA

Intervention Type 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

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing Tao

OTHER

Sponsor Role lead

Responsible Party

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Jing Tao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Fujian Provincial People's Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jing Tao, PhD

Role: CONTACT

(+86)0591-22861227

Qingping Su, MD

Role: CONTACT

(+86)15280409492

Facility Contacts

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Su Qingping, MD

Role: primary

15280409492

Lianghua Chen, MD

Role: primary

(+86) 15060026558

Yinghao Zhi, MD

Role: primary

(+86) 13758472924

Other Identifiers

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FujianUTCM-7

Identifier Type: -

Identifier Source: org_study_id

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