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Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

Primary Purpose

Stroke, Hemiplegia

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
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, Cerebrovascular disease, hemiplegia, Transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS, rehabilitation, Upper Extremity

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • single mono-hemispheric ischemic or hemorrhagic stroke
  • 1st onset stroke patient
  • Upper extremity functional deficit attributable to acute stroke
  • A stage of at least 3 on brunnström pre-treatment
  • Written signed consent

Exclusion Criteria:

  • Multiple lesion
  • Bilateral cortical lesion and motor problems
  • Cerebellar, or brainstem lesions
  • History of more than one stroke
  • Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
  • Increased intracranial pressure
  • History of seizure confirmed by interview and medical chart review
  • Any individual who is on medication which is known to lower seizure threshold
  • Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
  • An age of less than 20 years old
  • Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
  • Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
  • Inability to cooperate outcome measure-related task
  • Severe language disturbances
  • Serious cognitive deficits
  • Non-vascular cause for the neurological symptoms other central nervous system
  • Disorder or peripheral neuropathy of the upper extremity
  • Taking medication which interrupt brain activity
  • Women who are pregnant

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham rTMS-Sham rTMS

Sham rTMS-Real rTMS

Real rTMS-Real rTMS

Arm Description

Sham rTMS for 2 weeks

Sham rTMS in the first week and real rTMS in the second week

Real rTMS for 2 weeks

Outcomes

Primary Outcome Measures

Change in the Fugl-Meyer Assessment scale (upper extremity)

Secondary Outcome Measures

Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage

Full Information

First Posted
March 4, 2011
Last Updated
May 18, 2015
Sponsor
Seoul National University Bundang Hospital
Collaborators
Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01311271
Brief Title
Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke
Official Title
Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS. The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients. Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Stroke, Cerebrovascular disease, hemiplegia, Transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS, rehabilitation, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham rTMS-Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS for 2 weeks
Arm Title
Sham rTMS-Real rTMS
Arm Type
Experimental
Arm Description
Sham rTMS in the first week and real rTMS in the second week
Arm Title
Real rTMS-Real rTMS
Arm Type
Experimental
Arm Description
Real rTMS for 2 weeks
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Other Intervention Name(s)
TAMAS
Intervention Description
1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, Real: unaffected M1 hotspot Sham: coil perpendicular to scalp
Primary Outcome Measure Information:
Title
Change in the Fugl-Meyer Assessment scale (upper extremity)
Time Frame
Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Secondary Outcome Measure Information:
Title
Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage
Time Frame
Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single mono-hemispheric ischemic or hemorrhagic stroke 1st onset stroke patient Upper extremity functional deficit attributable to acute stroke A stage of at least 3 on brunnström pre-treatment Written signed consent Exclusion Criteria: Multiple lesion Bilateral cortical lesion and motor problems Cerebellar, or brainstem lesions History of more than one stroke Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease; Increased intracranial pressure History of seizure confirmed by interview and medical chart review Any individual who is on medication which is known to lower seizure threshold Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family An age of less than 20 years old Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke Complications that would prevent participation in the intervention, such as severe pain and severe spasticity Inability to cooperate outcome measure-related task Severe language disturbances Serious cognitive deficits Non-vascular cause for the neurological symptoms other central nervous system Disorder or peripheral neuropathy of the upper extremity Taking medication which interrupt brain activity Women who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

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