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The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

Primary Purpose

Stroke, Hemiplegia, Subcortical Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low-frequency rTMS (experimental)
Low-frequency rTMS (sham comparator)
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial magnetic stimulation, Rehabilitation, Neuronal plasticity, Subcortical infarction

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 19-80 years old
  • Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
  • Fugl-Meyer assessment scale (upper extremity) > 15
  • Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function
  • Written informed consent

Exclusion Criteria:

  • Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1
  • Hemorrhagic stroke or traumatic brain injury
  • Cerebellar stroke
  • Previous history of stroke
  • Traumatic brain injury
  • Previous history of brain surgery
  • Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)
  • History of psychological or neurological diseases
  • History of pain or muscular weakness of upper limbs which may interfere with rehabilitation
  • History of seizure or epilepsy
  • Aphasia
  • Skin lesions in the stimulation site of scalp
  • Intracranial metal implant
  • Inability to receive regular physical or occupational therapy
  • Disagreement to use contraception in women of childbearing age

Sites / Locations

  • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
  • Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real rTMS

sham rTMS

Arm Description

Use the real rTMS coil

Use the sham rTMS coil

Outcomes

Primary Outcome Measures

Box and Block test
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

Secondary Outcome Measures

Box and Block test
Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
Fugl-Meyer Assessment Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
modified Barthel Index (the Korean version)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
National Institutes of Health Stroke Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Finger tapping
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Brunnstrom stage (hand and arm)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

Full Information

First Posted
September 7, 2022
Last Updated
September 7, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
REMED, Chungnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05535504
Brief Title
The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke
Official Title
Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
REMED, Chungnam National University Hospital

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
The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke
Detailed Description
After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement. Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations. The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Subcortical Infarction
Keywords
Stroke, Transcranial magnetic stimulation, Rehabilitation, Neuronal plasticity, Subcortical infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real rTMS
Arm Type
Experimental
Arm Description
Use the real rTMS coil
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
Use the sham rTMS coil
Intervention Type
Device
Intervention Name(s)
Low-frequency rTMS (experimental)
Intervention Description
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp
Intervention Type
Device
Intervention Name(s)
Low-frequency rTMS (sham comparator)
Intervention Description
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp
Primary Outcome Measure Information:
Title
Box and Block test
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Secondary Outcome Measure Information:
Title
Box and Block test
Description
Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
Time Frame
upto 14 days
Title
Fugl-Meyer Assessment Scale
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
modified Barthel Index (the Korean version)
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
National Institutes of Health Stroke Scale
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
Finger tapping
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
Brunnstrom stage (hand and arm)
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Title
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Description
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days
Other Pre-specified Outcome Measures:
Title
Vital sign
Description
Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS
Time Frame
upto 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19-80 years old Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days Fugl-Meyer assessment scale (upper extremity) > 15 Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function Written informed consent Exclusion Criteria: Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1 Hemorrhagic stroke or traumatic brain injury Cerebellar stroke Previous history of stroke Traumatic brain injury Previous history of brain surgery Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability) History of psychological or neurological diseases History of pain or muscular weakness of upper limbs which may interfere with rehabilitation History of seizure or epilepsy Aphasia Skin lesions in the stimulation site of scalp Intracranial metal implant Inability to receive regular physical or occupational therapy Disagreement to use contraception in women of childbearing age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Kee Chang, MD
Phone
82-031-787-7739
Email
wonkee.chang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yeo Kyung Yoon
Phone
82-031-787-7739
Email
yyk97504@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Korea, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Kyun Sohn, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

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