The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

Study Overview
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Brief Summary
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To test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD) and to establish its safety in this population. The investigators 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.

Detailed Description
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PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while off will be recruited. Participants on antidepressants should be at least 2 months on stable therapy. Patient will be excluded if: They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative. Are on neuroleptics. Have dementia or any unstable medical disorder. Have a history or current unstable hypertension. Have a history of head injury or neurosurgical interventions. Have a history of any metal in the head (outside the mouth). Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes). The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30 and 60 Evaluation will be while subjects both at on and off. Motor: Unified Parkinson's Disease Rating Scale (UPDRS ) Clinical Global Impression of Severity (CGIS) Pegboard test. Tapping test Up & Go test Abnormal Involuntary Movement Scale (AIMS) Mood and affect 1. Beck Depression Inventory (BDI) Cognition Mini mental State examination (MMSE) Digit forward and backward tests. Word fluency. Frontal Assessment Battery (FAB) Side effects will be closely monitored by the researchers and will be promptly reported to the IRB. 8.Have a history of migraine or frequent or severe headaches. 9.Have a history of hearing loss. 10.Has a of cochlear implants 11.Have a history of drug abuse or alcoholism. 12.Is pregnant or not using a reliable method of birth control. 13.Is participating in current clinical study or clinical study within 30 days prior to this study.

Conditions
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UPDRS

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PD patients with asymmetric disease 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 unstable hypertension. History of head injury or neurosurgical interventions. History of any metal in the head (outside the mouth).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active repetitive transcranial Stimulation<br>Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes). | Device: repetitive transcranial stimulation (r-TMS)<br>* Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS ) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB |  | 1 year | 
| UPDRS |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson, rTMS