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

NCT ID: NCT01940406

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Essential Tremor; Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulation procedure

Stimulation procedure

Group Type: EXPERIMENTAL

Stimulation procedure

Intervention Type: PROCEDURE

Device

Interventions

Stimulation procedure

Device

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BlueWind Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirley Giorini Silfen, PhD

Role: STUDY_DIRECTOR

BlueWind Medical

Locations

Department of Neurology, Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

CP-01-001

Identifier Type: -

Identifier Source: org_study_id