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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson Disease; Essential Tremor
• Intervention / Treatment: Procedure: Stimulation procedure

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Department of Neurology, Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation procedure	Procedure: Stimulation procedure; Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: BlueWind Medical
• Investigators: Study Director: Shirley Giorini Silfen, PhD, BlueWind Medical

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: September 8, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Parkinson Disease; Essential Tremor; Electrical Stimulation; Tremor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor; Essential Tremor
• Other Study ID Numbers: CP-01-001