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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01940406
• Other study ID #: CP-01-001
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2013
• Last updated: February 22, 2018
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2018
• Source: Rainbow Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Tremor

Intervention

Procedure:
• Stimulation procedure
Device

Locations

Country	Name	City	State
Israel	Department of Neurology, Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Rainbow Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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