Protocol Number: 08-N-0212
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by iTBS and its safety in PD patients. Study population Patients (40-80 years of age) with PD, Hoehn and Yahr disease stage of 2 to 4 while off , being on a regimen including levodopa with a total dose of medication equal to more than 300 mg of levodopa including their dopamine agonist agents, and having problems with walking and needing 6 seconds or more to walk a 10-meter distance. Design Randomized, double-blind, placebo (sham)-controlled study. Enrollment of 30 patients with PD in 2 groups (real versus sham stimulation). Performance (8 interventions) of iTBS with large circular coil over motor and prefrontal cortex on both sides. Assessment with standard tests of motor function over a one-month period. Outcome measure The primary endpoint is change in gait speed as assessed by the time it takes to walk 10 m. Secondary endpoints include changes in bradykinesia as assessed by measuring the time it takes to do ten combined hand and arm movements, and in total and motor UPDRS score.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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