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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01940406
Recruitment Status : Withdrawn (Internal desicions)
First Posted : September 12, 2013
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
BlueWind Medical

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.

Condition or disease Intervention/treatment Phase
Essential Tremor Parkinson Disease Procedure: Stimulation procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction
Study Start Date : October 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Stimulation procedure
Stimulation procedure
Procedure: Stimulation procedure

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01940406

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Department of Neurology, Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
BlueWind Medical
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Study Director: Shirley Giorini Silfen, PhD BlueWind Medical
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Responsible Party: BlueWind Medical Identifier: NCT01940406    
Other Study ID Numbers: CP-01-001
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Keywords provided by BlueWind Medical:
Essential Tremor
Parkinson Disease
Electrical Stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms