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

NCT ID: NCT07210944

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2027-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Extremity Acupuncture Therapy Stroke Transcranial Magnetic Stimulation Repetitive Motor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Repeat transcranial magnetic stimulation and conventional treatment

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type 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.

Conventional rehabilitation treatment

Intervention Type 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.

experimental group

Repeat transcranial magnetic stimulation and scalp acupuncture and conventional treatment

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type 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.

Scalp acupuncture

Intervention Type 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.

Conventional rehabilitation treatment

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Debiao Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Debiao Kong

resident physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Debiao Kong

Role: CONTACT

+8618334350769

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Debiao Kong

Role: primary

+8618334350769

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZSLL-KY-2025-046

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.