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

Not Applicable

Withdrawn

• Conditions: Parkinson Disease; Essential Tremor
• Interventions: Procedure: Stimulation procedure

• Registration Number: NCT01940406
• Lead Sponsor: BlueWind Medical

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-09-08
• Study First Posted: 2013-09-12
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation procedure	Stimulation procedure	Stimulation procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improvement in tremor symptoms during the procedure	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	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

Trial Locations

Locations (1)

Department of Neurology, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel