The Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study

Study Overview
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Brief Summary
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The current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in ET and PD patients.

Detailed Description
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This study will evaluate the effect of Rainbow Medical's stimulation procedure methodology that will be applied temporarily to patients suffering of tremor. This will be evaluated by assessment of reduction of tremor using accelerometer measurements, patient tremor evaluation diary, tremor rating scale, and the Unified Parkinson's Disease Rating Scale (UPRDS) part III.In addition,tasks for patient with tremor will be conducted before during and after the treatment. The above measurements will provide data on the stimulation procedure effect as compared to baseline.

Official Title
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The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction

Conditions
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Essential Tremor, Parkinson Disease

Intervention / Treatment
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* Procedure: Stimulation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to Sign written informed consent in Hebrew. Patient agrees to attend all treatment procedures and follow-up evaluations and is willing and able to comply with all study requirements. Patient with a clinical diagnosis of idiopathic PD, or ET for more than 3 years. Significant tremor for at least one upper limb causing distress or disability. Patient should be stable on anti-Parkinson's disease or anti-tremor medication for at least one month prior to study enrollment. Exclusion Criteria: Previous participation in another study with any investigational drug or device within the past 90 days. Any active implant (cardiac or other). Current pregnancy or attempting to get pregnant (female patient). Patient has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study. Patient with other significant neurological or psychiatric disease other than Parkinson Disease or Essential Tremor. Patient has any other condition expect for PD and ET that induce tremor. Patient is treated with drug that may induce tremor. Patient abuses drugs or alcohol. Any previous thalamotomy, pallidotomy or patient who has undergone a DBS procedure. Any anticipated need for surgery during the study. Any malignancy in the past 2 years. Patient has confirmation of diagnosis of a terminal illness associated with survival <12 months.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation procedure<br>Stimulation procedure | Procedure: Stimulation procedure<br>* Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severe adverse events rate within the procedure |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in tremor symptoms during the procedure | Improvement after treatment in ET and PD tremor symptoms in comparison to baseline, as measured by change in: UPDRS part III scale Clinical Tremor Rating Scale Accelerometer values Patient tremor evaluation diary | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential Tremor, Parkinson Disease, Electrical Stimulation, Tremor