Parkinson's Disease Clinical Trial
Official title:
The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease
The aim of the study is to test the effects of low frequency deep rTMS using the novel
H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease
(PD) and to establish its safety in this population.
The investigators anticipate to recruit 10 patients to an open pilot study. All patients
will receive an active rTMS stimulation and will be given 12 treatment sessions, over a
period of up to 4 weeks. Each of the 12 daily treatment sessions (lasting about 30 minutes
each), will be consisted of 25 stimulation trains over the prefrontal cortex (20Hz trains, 2
seconds each with an inter-train interval of 20 seconds) and one train of 15 minutes at 1 Hz
over the the motor cortex.
The following outcome measures will be taken prior to the treatment (screening visit), and
at day 1, 10, 30, 60, and 90:
1. Unified Parkinson's Disease Rating Scale (UPDRS )
2. Clinical Global Impression of Severity (CGIS)
3. Pegboard test.
4. Tapping test
5. Up & Go test
6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect Beck Depression Inventory
(BDI) Cognition
1. Mini mental State examination (MMSE) 2. Digit forward and backward tests. 3. Word
fluency. 4. Frontal Assessment Battery (FAB)
Side effects will be closely monitored by the researchers and will be promptly reported to
the IRB
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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