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
1 other identifier
interventional
180
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2025
Typical duration for not_applicable stroke
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
August 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 5, 2025
September 1, 2025
1.9 years
August 3, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment (FMA)
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.
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Secondary Outcomes (4)
Arm Research Action Test (ARAT)
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Functional Ambulation Classification (FAC)
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Modified Barthel Index (MBI)
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Stroke-Specific Quality of Life Scale (SS-QOL)
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Other Outcomes (4)
Kinematic Analysis of Upper Limb Motor Tasks
Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Blood Biomarkers
Baseline, 2 weeks post-intervention
Electrophysiological Assessments (EMG, EEG, TMS)
Baseline, 2 weeks post-intervention
- +1 more other outcomes
Study Arms (2)
Active rTMS + Active EA group
EXPERIMENTALActive rTMS + Sham EA group
SHAM COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jing Taolead
Study Sites (3)
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial People's Hospital
Fuzhou, Fujian, 350004, China
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 3, 2025
First Posted
August 11, 2025
Study Start
August 27, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share