NCT04570774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

3.1 years

First QC Date

September 21, 2020

Last Update Submit

October 1, 2024

Conditions

StrokeRepetitive Transcranial Magnetic StimulationrTMSMotor Recovery

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Study Arms (4)

Facilitatory cerebral and cerebellar rTMS group

EXPERIMENTAL

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

Facilitatory cerebral rTMS group

ACTIVE COMPARATOR

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

Inhibitory cerebral and cerebellar rTMS group

EXPERIMENTAL

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

Inhibitory cerebral rTMS group

ACTIVE COMPARATOR

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

Interventions

Repetitive transcranial magnetic stimulationPROCEDURE

rTMS over cerebral motor cortex and cerebellar hemisphere

Facilitatory cerebral and cerebellar rTMS groupFacilitatory cerebral rTMS groupInhibitory cerebral and cerebellar rTMS groupInhibitory cerebral rTMS group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 30, 2020

Study Start

October 2, 2020

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study will be available from the principal investigator upon reasonable request.

Locations

KR(1)