Effect of Cerebral and Cerebellar rTMS in Stroke Patient

Sponsor

Samsung Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04570774

Collaborator

(none)

Enrollment

Locations

Arms

38.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Repetitive Transcranial Magnetic Stimulation rTMS Motor Recovery	Procedure: Repetitive transcranial magnetic stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients

Actual Study Start Date :

Sep 2, 2020

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Repetitive transcranial magnetic stimulation rTMS over cerebral motor cortex and cerebellar hemisphere
Active Comparator: 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.	Procedure: Repetitive transcranial magnetic stimulation rTMS over cerebral motor cortex and cerebellar hemisphere
Experimental: 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.	Procedure: Repetitive transcranial magnetic stimulation rTMS over cerebral motor cortex and cerebellar hemisphere
Active Comparator: 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.	Procedure: Repetitive transcranial magnetic stimulation rTMS over cerebral motor cortex and cerebellar hemisphere

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351
2	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Won Hyuk Chang, Associate Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT04570774

Other Study ID Numbers:

2020-06-068

First Posted:

Sep 30, 2020

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of May 9, 2022