Scalp Acupuncture Combined With rTMS for Upper Limb Motor Dysfunction in Stroke: A Brain Network Study

November 18, 2025 updated by: Debiao Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
Repeat transcranial magnetic stimulation and conventional treatment
Device: Repetitive transcranial magnetic stimulation
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.
Combination product: Conventional rehabilitation treatment
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.
Experimental: experimental group
Repeat transcranial magnetic stimulation and scalp acupuncture and conventional treatment
Device: Repetitive transcranial magnetic stimulation
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.
Combination product: Conventional rehabilitation treatment
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.
Procedure: Scalp acupuncture
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One day before treatment, four weeks after treatment
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.
One day before treatment, four weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: One day before treatment, four weeks after treatment
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.
One day before treatment, four weeks after treatment
Modified Barthel Index
Time Frame: One day before treatment, four weeks after treatment
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.
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
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.
One day before treatment, two weeks after treatment, four weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Debiao Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZSLL-KY-2025-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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