Upper ExtremityNCT07210944
Scalp Acupuncture Combined With rTMS for Upper Limb Motor Dysfunction in Stroke: A Brain Network Study
A study testing Repetitive transcranial magnetic stimulation, Scalp acupuncture and Conventional rehabilitation treatment in people with Upper Extremity and Acupuncture Therapy, run by Debiao Kong at 1 site in China.
Trial summary
This study aims to compare the improvement effects of the rTMS (repetitive transcranial magnetic stimulation) combined with conventional rehabilitation therapy group with the rTMS combined with scalp acupuncture and conventional rehabilitation therapy group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Extremity, Acupuncture Therapy, Stroke
- What is being tested?
- Repetitive transcranial magnetic stimulation, Scalp acupuncture and Conventional rehabilitation treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 30 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for stroke (symptoms and signs, imaging indicators, etc.), and are independently diagnosed by two deputy chief physicians
- Age 18-70 years old, first episode, duration 1-6 months
- The diagnostic criteria for upper limb dysfunction align with the Brunnstrom staging system: patients in Brunnstrom stages II to IV. Stage II: patients exhibit associative responses and can perform coordinated movements, with minimal voluntary movements; Stage III: patients show voluntary coordinated movements, such as grasping with the hand but not extending; Stage IV: patients can perform isolated movements, such as pinching with the hand and limited extension
- No severe visual or hearing impairment, able to cooperate with relevant assessments and tests
- The score of the Mini-Mental State Examination is ≥20 points
- Vital signs are stable, with no signs of progressive neurological symptoms
- The patient or legal guardian agrees and signs the informed consent form
Who cannot join
- Severe visual impairment, hemispatial neglect, body image disorder
- Individuals who cannot undergo rTMS treatment due to reasons such as metal implants, cardiac pacemakers, or skull defects
- Previous history of brain tumor, brain trauma, epilepsy, and risk of epileptic seizures
- Any other factors that affect assessment and treatment
- Dysfunction of limb movement caused by other reasons (such as trauma, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Debiao Kong, +8618334350769, 1372599678@qq.com
About this study
Official title: Research Protocol for a Randomized Controlled Trial on Brain Network Study of Upper Limb Motor Dysfunction in Stroke Patients Treated With Scalp Acupuncture Combined With rTMS
This study aims to compare the improvement effects of the rTMS (repetitive transcranial magnetic stimulation) combined with conventional rehabilitation therapy group with the rTMS combined with scalp acupuncture and conventional rehabilitation therapy group. Through statistical analysis of the results obtained from functional near-infrared spectroscopy technology during task states, the investigators elucidate the neuroregulatory mechanism of scalp acupuncture combined with rTMS in improving upper limb motor function in stroke patients under MEP localization, and provide evidence for a more optimal rehabilitation program for post-stroke upper limb motor dysfunction.
- Conditions
- Upper Extremity, Acupuncture Therapy, Stroke, Transcranial Magnetic Stimulation Repetitive, Motor Disorders
- Being tested
- Repetitive transcranial magnetic stimulation, Scalp acupuncture, Conventional rehabilitation treatment
- Keywords
- Conventional rehabilitation therapy, Scalp Acupuncture, Upper Limb, Repetitive Transcranial Magnetic Stimulation, Motor Disorders
- Medical subject headings
- Stroke, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Transcranial magnetic stimulation applied a figure-8 coil to the premotor area at 80%-100% of the healthy-side MEP threshold. Treatment lasted 20 min in two phases: weeks 1-2 on the ipsilateral M1 (1Hz, 10s on/5s off), and weeks 3-4 on the contralateral M1 (10Hz, 3s on/12s off). Treat once a day, 5 days a week, for a total of 4 weeks.
Scalp acupunctureProcedure or surgery
Scalp acupuncture selected bilateral upper-limb cortical MEP points (2 points total). The healthy-side hot spot was identified first; if the affected side had no MEP, its mirror point was used. Needles were inserted from point A (affected) to B (healthy) and beyond along the AB line. After insertion, needles were rotated for 2-3 min, manipulated every 10 min, and retained for 30 min. Treat once a day, 5 days a week, for a total of 4 weeks.
Conventional rehabilitation treatmentCombination product
Conventional drug therapy included secondary stroke prevention, neurotrophy, and improved cerebral circulation. Routine rehabilitation involved exercise, occupational, and physical therapies, with a total daily treatment time of 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Repeat transcranial magnetic stimulation and conventional treatment Receives: Device: Repetitive transcranial magnetic stimulation; Combination Product: Conventional rehabilitation treatment |
| experimental group | Experimental | Repeat transcranial magnetic stimulation and scalp acupuncture and conventional treatment Receives: Device: Repetitive transcranial magnetic stimulation; Procedure: Scalp acupuncture; Combination Product: Conventional rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum amplitude of motor evoked potential
It refers to the potential difference between the peak and trough of the motor evoked potential, reflecting the excitability of the cerebral cortex and neural pathways. It is detected using an RD-CCY type TMS stimulator in conjunction with a Viking Quest 4-channel surface electromyography recorder from the American company Neuropad.
Measured: One day before treatment, four weeks after treatment
Fugl-Meyer Assessment-Upper Extremities
It is a widely used standardized assessment tool in the rehabilitation of upper limb motor dysfunction after stroke. The FMA divides upper limb motor function into multiple dimensions, including reflex activity, coordinated movement, isolated movement, wrist and hand function, through systematic scoring items. A total of 33 items are included. Each item is scored on a 3-point scale (0-2 points), with a total score of 66 (upper limb part). Higher scores indicate better recovery of upper limb motor function.
Measured: One day before treatment, four weeks after treatment
Secondary outcomes (3)
Action Research Arm Test
It includes 4 parts: grasping, holding, pinching, and gross motor function, with a total of 19 items. Each item is scored on a 4-point scale (0-3 points), with a total of 57 points. The higher the score, the better the recovery of upper limb motor function.
Measured: One day before treatment, four weeks after treatment
Modified Barthel Index
It is used to assess patients' ability to perform activities of daily living. It includes 10 items: eating, dressing, using the toilet, defecating, urinating, grooming, bathing, climbing stairs, transferring, and walking. The total score ranges from 0 to 100, with higher scores indicating better ability to perform activities of daily living. A score of >60 indicates that the patient can live independently.
Measured: One day before treatment, four weeks after treatment
Functional near-infrared spectroscopy
Data were collected using a 35-channel fNIRS imaging device, NirSmart (HuiChuang, China), during resting state and scalp acupuncture stimulation. The device includes 17 light source probes and 14 detection probes, forming 35 effective channels in the experimental design, covering the forehead, bilateral frontal lobes, and motor areas. Continuous wave, near-infrared wavelength (760-850nm) signals were used with a sampling frequency of 11Hz, allowing real-time and effective monitoring of changes in the concentration of oxyhemoglobin and deoxyhemoglobin in the healthy side of the subject's brain. Based on coordinate information, the 35 channels were divided into five regions of interest in the left and right cerebral cortexes of the subject, namely the bilateral motor area, bilateral temporal lobe and forehead.
Measured: One day before treatment, two weeks after treatment, four weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start5 Dec 2025 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper ExtremityStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiao Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Debiao Kong, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210944
- Sponsor's protocol ID
- ZSLL-KY-2025-046
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong D, Huang X, Zhang S, Chen K, Gao H, Xie H. MEP-Guided Scalp Acupuncture Combined with Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Motor Impairment: A Randomized Controlled Study Protocol. Int J Gen Med. 2026 Feb 24;19:582719. doi: 10.2147/IJGM.S582719. eCollection 2026.
PubMed 41769053
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Protocol for a Randomized Controlled Trial on Brain Network Study of Upper Limb Motor Dysfunction in Stroke Patients Treated With Scalp Acupuncture Combined With rTMS
- ClinicalTrials.gov ID
- NCT07210944
- Acronym / sponsor ID
- ZSLL-KY-2025-046
- Conditions
- Upper Extremity, Acupuncture Therapy, Stroke, Transcranial Magnetic Stimulation Repetitive, Motor Disorders
- Keywords
- Conventional rehabilitation therapy, Scalp Acupuncture, Upper Limb, Repetitive Transcranial Magnetic Stimulation, Motor Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Debiao KongUniversity, hospital or other
- Study start
- 5 Dec 2025 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 7 Oct 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 compare the improvement effects of the rTMS (repetitive transcranial magnetic stimulation) combined with conventional rehabilitation therapy group with the rTMS combined with scalp acupuncture and conventional rehabilitation therapy group. Through statistical analysis of the results obtained from functional near-infrared spectroscopy technology during task states, the investigators elucidate the neuroregulatory mechanism of scalp acupuncture combined with rTMS in improving upper limb motor function in stroke patients under MEP localization, and provide evidence for a more optimal rehabilitation program for post-stroke upper limb motor dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: Repetitive transcranial magnetic stimulation, Combination Product: Conventional rehabilitation treatmentRepeat transcranial magnetic stimulation and conventional treatment |
| experimental group | Experimental | Device: Repetitive transcranial magnetic stimulation, Procedure: Scalp acupuncture, Combination Product: Conventional rehabilitation treatmentRepeat transcranial magnetic stimulation and scalp acupuncture and conventional treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for stroke (symptoms and signs, imaging indicators, etc.), and are independently diagnosed by two deputy chief physicians
- Age 18-70 years old, first episode, duration 1-6 months
- The diagnostic criteria for upper limb dysfunction align with the Brunnstrom staging system: patients in Brunnstrom stages II to IV. Stage II: patients exhibit associative responses and can perform coordinated movements, with minimal voluntary movements; Stage III: patients show voluntary coordinated movements, such as grasping with the hand but not extending; Stage IV: patients can perform isolated movements, such as pinching with the hand and limited extension
- No severe visual or hearing impairment, able to cooperate with relevant assessments and tests
- The score of the Mini-Mental State Examination is ≥20 points
Key exclusion criteria (5 listed)
- Severe visual impairment, hemispatial neglect, body image disorder
- Individuals who cannot undergo rTMS treatment due to reasons such as metal implants, cardiac pacemakers, or skull defects
- Previous history of brain tumor, brain trauma, epilepsy, and risk of epileptic seizures
- Any other factors that affect assessment and treatment
- Dysfunction of limb movement caused by other reasons (such as trauma, etc.)
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationTranscranial magnetic stimulation applied a figure-8 coil to the premotor area at 80%-100% of the healthy-side MEP threshold. Treatment lasted 20 min in two phases: weeks 1-2 on the ipsilateral M1 (1Hz, 10s on/5s off), and weeks 3-4 on the contralateral M1 (10Hz, 3s on/12s off). Treat once a day, 5 days a week, for a total of 4 weeks. | Device | control group, experimental group |
| Scalp acupunctureScalp acupuncture selected bilateral upper-limb cortical MEP points (2 points total). The healthy-side hot spot was identified first; if the affected side had no MEP, its mirror point was used. Needles were inserted from point A (affected) to B (healthy) and beyond along the AB line. After insertion, needles were rotated for 2-3 min, manipulated every 10 min, and retained for 30 min. Treat once a day, 5 days a week, for a total of 4 weeks. | Procedure or surgery | experimental group |
| Conventional rehabilitation treatmentConventional drug therapy included secondary stroke prevention, neurotrophy, and improved cerebral circulation. Routine rehabilitation involved exercise, occupational, and physical therapies, with a total daily treatment time of 90 minutes. | Combination product | control group, experimental group |
Primary outcome
Maximum amplitude of motor evoked potential
Time frame: One day before treatment, four weeks after treatment
It refers to the potential difference between the peak and trough of the motor evoked potential, reflecting the excitability of the cerebral cortex and neural pathways. It is detected using an RD-CCY type TMS stimulator in conjunction with a Viking Quest 4-channel surface electromyography recorder from the American company Neuropad.
Fugl-Meyer Assessment-Upper Extremities
Time frame: One day before treatment, four weeks after treatment
It is a widely used standardized assessment tool in the rehabilitation of upper limb motor dysfunction after stroke. The FMA divides upper limb motor function into multiple dimensions, including reflex activity, coordinated movement, isolated movement, wrist and hand function, through systematic scoring items. A total of 33 items are included. Each item is scored on a 3-point scale (0-2 points), with a total score of 66 (upper limb part). Higher scores indicate better recovery of upper limb motor function.
3 secondary outcomes
Action Research Arm Test
Time frame: One day before treatment, four weeks after treatment
Modified Barthel Index
Time frame: One day before treatment, four weeks after treatment
Functional near-infrared spectroscopy
Time frame: One day before treatment, two weeks after treatment, four weeks after treatment
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 19 Nov 2025.
- Derived from this study: PubMed 41769053Kong D, Huang X, Zhang S, Chen K, Gao H, Xie H. MEP-Guided Scalp Acupuncture Combined with Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Motor Impairment: A Randomized Controlled Study Protocol. Int J Gen Med. 2026 Feb 24;19:582719. doi: 10.2147/IJGM.S582719. eCollection 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation, Scalp acupuncture and Conventional rehabilitation treatment in people with Upper Extremity and Acupuncture Therapy, run by Debiao Kong at 1 site 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 5 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Debiao Kong (+8618334350769, 1372599678@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum amplitude of motor evoked potential (time frame: One day before treatment, four weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210944, which also lists 1 linked publication.
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 19 Nov 2025.