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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Rainbow Medical
Sponsor:
Information provided by (Responsible Party):
Rainbow Medical
ClinicalTrials.gov Identifier:
NCT01940406
First received: July 16, 2013
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Essential Tremor
Parkinson Disease
Procedure: Stimulation procedure

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction

Resource links provided by NLM:


Further study details as provided by Rainbow Medical:

Primary Outcome Measures:
  • The severe adverse events rate within the procedure [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in tremor symptoms during the procedure [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 15
Study Start Date: October 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulation procedure
Stimulation procedure
Procedure: Stimulation procedure
Device

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940406

Contacts
Contact: Shirley Giorini Silfen, PhD +972 9 9531103 shirley@rainbowmd.com

Locations
Israel
Department of Neurology, Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Sharon Hassin, MD    972-3-5305791    shassin@post.tau.ac.il   
Principal Investigator: Sharon Hassin, MD         
Sponsors and Collaborators
Rainbow Medical
Investigators
Study Director: Shirley Giorini Silfen, PhD Rainbow Medical
  More Information

No publications provided

Responsible Party: Rainbow Medical
ClinicalTrials.gov Identifier: NCT01940406     History of Changes
Other Study ID Numbers: CP-01-001
Study First Received: July 16, 2013
Last Updated: September 8, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rainbow Medical:
Essential Tremor
Parkinson Disease
Electrical Stimulation
Tremor

Additional relevant MeSH terms:
Essential Tremor
Parkinson Disease
Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014