Individualized rTMS for Motor Recovery in Stroke Patients

NCT ID: NCT05914038

Last Updated: 2024-10-18

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2027-05-20

Brief Summary

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This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Detailed Description

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Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode.

However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index.

This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Conditions

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Stroke Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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individualized rTMS

Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.

Traditional rTMS

Control group is given traditional rTMS

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.

Interventions

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Repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Unilateral ischemic or hemorrhagic stroke
2. Stroke within 3 months
3. Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
4. No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
5. Patient could sit over 15 minutes
6. Age over 20

Exclusion Criteria

1. Previous stroke, traumatic brain injury, brain tumor
2. With central nervous system disease (spinal cord injury, Parkinson's disease)
3. Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
4. Patients unable to cooperate the treatment
5. Pregnancy
6. Depression
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meng Ting Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei County, Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Meng Ting Lin, M.D.

Role: CONTACT

+886-2312-3456 ext. 67048

Yan Ci Liu, PhD

Role: CONTACT

+886233668135

Facility Contacts

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Meng Ting Lin, M.D.

Role: primary

0223123456 ext. 67651

Other Identifiers

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202301225DIND

Identifier Type: -

Identifier Source: org_study_id

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