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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01311271

Collaborator

Asan Medical Center (Other), Gyeongsang National University Hospital (Other), Hanyang University (Other), Seoul National University Boramae Hospital (Other)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiplegia	Device: repetitive transcranial magnetic stimulation (rTMS)	Phase 2/Phase 3

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham rTMS-Sham rTMS Sham rTMS for 2 weeks	Device: repetitive transcranial magnetic stimulation (rTMS) 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 Other Names: TAMAS
Experimental: Sham rTMS-Real rTMS Sham rTMS in the first week and real rTMS in the second week	Device: repetitive transcranial magnetic stimulation (rTMS) 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 Other Names: TAMAS
Experimental: Real rTMS-Real rTMS Real rTMS for 2 weeks	Device: repetitive transcranial magnetic stimulation (rTMS) 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 Other Names: TAMAS

Arm

Intervention/Treatment

Sham Comparator: Sham rTMS-Sham rTMS

Sham rTMS for 2 weeks

Device: repetitive transcranial magnetic stimulation (rTMS)

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

Other Names:

TAMAS

Experimental: Sham rTMS-Real rTMS

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

Device: repetitive transcranial magnetic stimulation (rTMS)

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

Other Names:

TAMAS

Experimental: Real rTMS-Real rTMS

Real rTMS for 2 weeks

Device: repetitive transcranial magnetic stimulation (rTMS)

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

Other Names:

TAMAS

Outcome Measures

Primary Outcome Measures

Change in the Fugl-Meyer Assessment scale (upper extremity) [Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up]

Secondary Outcome Measures

Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage [Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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