Effect of Cerebral and Cerebellar rTMS in Stroke Patient

Not Applicable

Completed

• Conditions: Stroke; rTMS; Motor Recovery; Repetitive Transcranial Magnetic Stimulation
• Interventions: Procedure: Repetitive transcranial magnetic stimulation

• Registration Number: NCT04570774
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2020-10-02
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitatory cerebral and cerebellar rTMS group	Repetitive transcranial magnetic stimulation	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.
Facilitatory cerebral rTMS group	Repetitive transcranial magnetic stimulation	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.
Inhibitory cerebral and cerebellar rTMS group	Repetitive transcranial magnetic stimulation	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.
Inhibitory cerebral rTMS group	Repetitive transcranial magnetic stimulation	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.

Primary Outcome Measures

Name	Time	Method
Difference of upper limb motor score in Fugl-Meyer assessment	2 weeks	(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline); Higher scores mean a better outcome

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of