Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to test the effects of 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.

Detailed Description
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Study rational:We anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder. Design:A prospective, double blind sham-controled study. No. of centers:1 One: Tel-Hashomer Medical Center, affiliated to Sackler school of Medicine, Tel -Aviv University, Israel. Study Population:Forty patients with idiopathic PD, Hoehn and Yahr stages II to IV, on stable antiparkinsonian therapy, with partial response. Study Duration:Two years

Official Title
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Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: repetitive transcranial stimulation (r-TMS)
* Device: Repetitive transcranial stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while off. Participants on antidepressants should be at least 2 months on stable therapy. Exclusion Criteria: Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative. Patients on neuroleptics. Patients with dementia or any unstable medical disorder. History or current hypertension. History of head injury or neurosurgical interventions. History of any metal in the head (outside the mouth). Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. History of migraine or frequent or severe headaches. History of hearing loss. The presence of cochlear implants History of drug abuse or alcoholism. Pregnancy or not using a reliable method of birth control. Participation in current clinical study or clinical study within 30 days prior to this study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex. | Device: repetitive transcranial stimulation (r-TMS)<br>* Each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (active) over the motor cortex and the prefrontal cortex.<br>|
| Sham Comparator: Placebo<br>Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of 20Hz stimulation trains (sham) over the motor cortex and the prefrontal cortex. | Device: Repetitive transcranial stimulation<br>* Sham treatment group: each patient will be given 3 treatment sessions per week for 4 weeks (a total of 12 sessions). Each session is 20 minutes long and will be consisted of sham stimulation trains over the motor cortex and the prefrontal cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part) |  | 10-90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Severity (CGIS) |  | 10-90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial stimulation, Parkinson's Disease