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
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
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
NCT ID
NCT01311271
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
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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