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

NCT07210944 | Not Yet Recruiting

• 1 other identifier: ZSLL-KY-2025-046
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Conventional rehabilitation therapy; Scalp Acupuncture; Upper Limb; Repetitive Transcranial Magnetic Stimulation; Motor Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  One day before treatment, four weeks after treatment

Secondary Outcomes (3)

• Action Research Arm Test

  One day before treatment, four weeks after treatment

• Modified Barthel Index

  One day before treatment, four weeks after treatment

• Functional near-infrared spectroscopy

  One day before treatment, two weeks after treatment, four weeks after treatment

Study Arms (2)

control group

ACTIVE COMPARATOR

Repeat transcranial magnetic stimulation and conventional treatment

Device: Repetitive transcranial magnetic stimulation; Combination Product: Conventional rehabilitation treatment

experimental group

EXPERIMENTAL

Repeat transcranial magnetic stimulation and scalp acupuncture and conventional treatment

Device: Repetitive transcranial magnetic stimulation; Procedure: Scalp acupuncture; Combination Product: Conventional rehabilitation treatment

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

control group; experimental group

Scalp acupuncture PROCEDURE

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.

experimental group

Conventional rehabilitation treatment COMBINATION_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.

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Debiao Kong: lead

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Stroke; Motor Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Debiao Kong

CONTACT

+8618334350769; 1372599678@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)