Effect of Cerebral and Cerebellar rTMS in Stroke Patient

NCT ID: NCT04570774

Last Updated: 2024-10-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2023-11-30

Brief Summary

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This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.

Detailed Description

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Conditions

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Stroke Repetitive Transcranial Magnetic Stimulation rTMS Motor Recovery

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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Facilitatory cerebral and cerebellar rTMS group

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

rTMS over cerebral motor cortex and cerebellar hemisphere

Facilitatory cerebral rTMS group

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and sham high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

rTMS over cerebral motor cortex and cerebellar hemisphere

Inhibitory cerebral and cerebellar rTMS group

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

rTMS over cerebral motor cortex and cerebellar hemisphere

Inhibitory cerebral rTMS group

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and sham rTMS over the ipsilateral cerebellar hemisphere.

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

rTMS over cerebral motor cortex and cerebellar hemisphere

Interventions

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Repetitive transcranial magnetic stimulation

rTMS over cerebral motor cortex and cerebellar hemisphere

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Hemiplegic stroke patients within 1 month after onset
* Moderate to severe motor impairment (Fugl-Meyer assessment \<85)
* Cognitive and language functions to perform more than one step of command
* More than 19 years old

Exclusion Criteria

* Contraindicated to rTMS
* Progressive or unstable stroke
* Pre-existing and active major neurological disease or major psychiatric disease
* A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival \<1 year
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Hyuk Chang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-06-068

Identifier Type: -

Identifier Source: org_study_id

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