Status:
COMPLETED
Influence of Theta Burst Stimulation and Carbidopa-Levodopa on Motor Performance in Stroke Patients
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Brief Summary
This study will examine whether transcranial magnetic stimulation (TMS) of the brain used in combination with carbidopa-levodopa is more effective in temporarily improving the speed of hand movement i...
Detailed Description
OBJECTIVE: Theta Burst Stimulation (TBS) is a type of sub-threshold repetitive Transcranial Magnetic Stimulation (rTMS) which has effects on the excitability of human motor cortex that outlast stimul...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- PATIENTS:
- Age 18 - 90
- Ischemic cerebral infarction more than 6 months prior to testing not involving cortical motor areas
- Initial severe paresis (MRC Grade 2 or less in hand muscles) with considerable motor recovery
- Ability to make ballistic thumb abduction or wrist extension movements in the affected hand
- HEALTHY SUBJECTS:
- Age 18 - 90
- Right handed
- Able to concentrate and to perform the tasks required
- EXCLUSION CRITERIA:
- PATIENTS:
- More than one ischemic stroke, or any hemorrhagic stroke
- Large cortical stroke
- Significant cognitive impairment, defined as a Mini Mental State Examination score of 23 or less
- History of seizures or other neurological illness (except stroke)
- History of alcohol or drug abuse
- Inability to make necessary thumb abduction or wrist extension movements
- Current or recent use of neuroleptic medication, tricyclic anti-depressants or monoamine oxidase inhibitors
- History of narrow angle glaucoma
- Contraindications to TMS - presence of cardiac pacemaker, intracardiac lines, implanted pumps or stimulators, or metal objects inside the eye or skull
- Pregnancy (as the effects of TBS on the fetus are as yet unknown)
- Uncontrolled medical (e.g. cardiovascular disease expressed as uncontrolled arrhythmias, shortness of breath, or overt signs of severe peripheral edema at the initial neurological exam, severe rheumatoid arthritis, arthritic joint deformity, active cancer or renal disease), or psychiatric problems (defined as having received medical treatment from a psychiatrist).
- HEALTHY SUBJECTS:
- Contraindications to TMS (as above)
- Pregnancy (see above)
- History of seizures or other neurological illness
- History of alcohol or drug abuse
- History of depression / psychiatric illness requiring use of anti-psychotic drugs or anti-depressants
- Current or recent use of neuroleptic medication, tricyclic anti-depressants or monoamine oxidase inhibitors
- History of narrow angle glaucoma
Exclusion
Key Trial Info
Start Date :
August 8 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00366184
Start Date
August 8 2006
End Date
May 26 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892