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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation procedure | Experimental | Stimulation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation procedure | Procedure | Device |
|
| 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 |
| 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:
| participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Giorini Silfen, PhD | BlueWind Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
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| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |