Influence of Theta Burst Stimulation and Carbidopa-Levodopa on Motor Performance in Stroke Patients
Completed
Conditions studied: Stroke
In brief
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 in stoke patients than TMS alone. In TMS, a wire coil is held on the patient's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. Carbidopa-levodopa is a medication usually used to treat Parkinson's disease, but it may improve the effect of theta burst stimulation. Two kinds of TMS are used in this study. In single-pulse TMS one or two pulses are delivered at a time in order to measure brain activity at that moment. In repetitive TMS (rTMS), a series of pulses are given in short bursts, temporarily altering brain activity. The type of rTMS used in this study is called theta burst stimulation. Healthy normal volunteers and people who had a stroke 6 months or more before entering the study may be eligible to participate. All candidates must be between 18 and 90 years of age. Stroke patients must have had significant hand weakness and made a moderate or good recovery and must be able to move either the thumb or the wrist on the affected hand reasonably well. Normal volunteers must be right-handed. Participants complete the testing for this study in four main sessions scheduled at least a week apart and five short follow-up sessions. At each main session, participants take either a carbidopa-levodopa tablet or a placebo (a look-alike inactive substance). Stroke patients have their arm and hand function assessed using two tests. One requires them to insert pegs into holes; the other includes writing, lifting various objects, and performing activities like turning pages, feeding or stacking checkers. All subjects complete a questionnaire regarding their mood and alertness and then perform tests of thumb or wrist movement. For this test, a small electrical stimulus is applied to the side of the hand and the subject must respond to the stimulus as quickly as possible by making a thumb or wrist movement. This is repeated several times over about 3 minutes. A second test follows in which the subject moves the thumb or wrist in response to a beep from a speaker. This test is repeated several times over about 8 minutes. Some measurements are taken using single-pulse TMS during the beginning, middle and end of this test. In two of the four sessions, theta burst stimulation is applied after the single-pulse TMS and in the other two sessions, sham theta burst stimulation is applied. Five follow-up sessions are scheduled one day after each main session and one week following the final one. In these sessions, subjects perform an abbreviated form of the thumb movement tests.
Key facts
- Study ID
- NCT00366184
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 20
- Starts
- 2006-08-08
- Expected to finish
- 2010-05-26
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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