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Effect of Cerebral and Cerebellar rTMS in Stroke Patient

Primary Purpose

Stroke, Repetitive Transcranial Magnetic Stimulation, rTMS

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical CenterRecruiting
  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Facilitatory cerebral and cerebellar rTMS group

Facilitatory cerebral rTMS group

Inhibitory cerebral and cerebellar rTMS group

Inhibitory cerebral rTMS group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Difference of upper limb motor score in Fugl-Meyer assessment
(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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2020
Last Updated
May 5, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04570774
Brief Title
Effect of Cerebral and Cerebellar rTMS in Stroke Patient
Official Title
Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Repetitive Transcranial Magnetic Stimulation, rTMS, Motor Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Facilitatory cerebral and cerebellar rTMS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Facilitatory cerebral rTMS group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inhibitory cerebral and cerebellar rTMS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Inhibitory cerebral rTMS group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
rTMS over cerebral motor cortex and cerebellar hemisphere
Primary Outcome Measure Information:
Title
Difference of upper limb motor score in Fugl-Meyer assessment
Description
(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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Hyuk Chang, MD.,PhD.
Phone
82-2-3410-6068
Email
wh.chang@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Hyuk Chang, Prof
Phone
82-2-3410-6068
Email
wh.chang@samsung.com
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Hyuk Chang, MD., PhD.
Phone
82-2-3410-6068
Email
wh.chang@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study will be available from the principal investigator upon reasonable request.

Learn more about this trial

Effect of Cerebral and Cerebellar rTMS in Stroke Patient

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