StrokeNCT07113990
Electroacupuncture and rTMS for Post-Stroke Motor Recovery
A study testing Active EA and Active rTMS in people with Stroke, run by Jing Tao at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active EA and Active rTMS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 27 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Severe spasticity (modified Ashworth ≥ 2).
- Fear or intolerance of TMS or electroacupuncture.
- Pregnancy, breastfeeding, or concurrent participation in other clinical trials affecting outcomes.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Qingping Su, MD contact
China3 sites, 3 recruiting
- Recruiting
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001
Su Qingping, MD, 15280409492, sy1462@fzu.edu.cn
Qingping Su, MD
- Not yet recruiting
Fujian Provincial People's Hospital
Fuzhou, Fujian, 350004
Lianghua Chen, MD, (+86) 15060026558, 82987169@qq.com
Lianghua Chen, MD
- Not yet recruiting
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, 325000
Yinghao Zhi, MD, (+86) 13758472924, 43914515@qq.com
Yinghao Zhi, MD
About this study
Official title: Efficacy and Safety of Electroacupuncture Combined With rTMS on Motor Function Recovery After Stroke: A Multi-center Randomized Controlled Clinical Study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Active EA, Sham EA, Active rTMS
- Keywords
- Electroacupuncture; Repetitive Transcranial Magnetic Stimulation (rTMS); Stroke Rehabilitation; Motor Function ; Multicenter Randomized Controlled Trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active EAProcedure or surgery
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 EAProcedure or surgery
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 rTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS + Active EA group | Experimental | Not described Receives: Procedure: Active EA; Device: Active rTMS |
| Active rTMS + Sham EA group | Sham comparator | Not described Receives: Procedure: Sham EA; Device: Active rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Secondary outcomes (4)
Arm Research Action Test (ARAT)
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.
Measured: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Functional Ambulation Classification (FAC)
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.
Measured: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Modified Barthel Index (MBI)
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.
Measured: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Stroke-Specific Quality of Life Scale (SS-QOL)
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.
Measured: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start27 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Tao, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113990
- Sponsor's protocol ID
- FujianUTCM-7
- Status last verified
- Sep 2025
- First submitted
- 3 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Electroacupuncture Combined With rTMS on Motor Function Recovery After Stroke: A Multi-center Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07113990
- Acronym / sponsor ID
- FujianUTCM-7
- Conditions
- Stroke
- Keywords
- Electroacupuncture; Repetitive Transcranial Magnetic Stimulation (rTMS); Stroke Rehabilitation; Motor Function ; Multicenter Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jing TaoUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS + Active EA group | Experimental | Procedure: Active EA, Device: Active rTMS |
| Active rTMS + Sham EA group | Sham comparator | Procedure: Sham EA, Device: Active rTMS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active EAParticipants 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 or surgery | Active rTMS + Active EA group |
| Sham EAParticipants 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. | Procedure or surgery | Active rTMS + Sham EA group |
| Active rTMSParticipants 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. | Device | Active rTMS + Active EA group, Active rTMS + Sham EA group |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qingping Su, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active EA and Active rTMS in people with Stroke, run by Jing Tao at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Tao, PhD ((+86)0591-22861227, taojing01@fjtcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.