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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

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
Intervention / Treatment
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

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

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

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)

December 5, 2025

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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