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

NCT01940406 | Withdrawn DMC

• 1 other identifier: CP-01-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor; Parkinson Disease

Keywords

Essential Tremor; Parkinson Disease; Electrical Stimulation; Tremor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in tremor symptoms during the procedure

  participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (1)

Stimulation procedure

EXPERIMENTAL

Stimulation procedure

Procedure: Stimulation procedure

Interventions

Stimulation procedure PROCEDURE

Device

Stimulation procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BlueWind Medical: lead

Study Sites (1)

Department of Neurology, Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shirley Giorini Silfen, PhD

  BlueWind Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: September 12, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

IL (1)