Back to resultsThe Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study
Primary Purpose
Essential Tremor, Parkinson Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Stimulation procedure
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Essential Tremor, Parkinson Disease, Electrical Stimulation, Tremor
Eligibility 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.
Sites / Locations
- Department of Neurology, Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stimulation procedure
Arm Description
Stimulation procedure
Outcomes
Primary Outcome Measures
The severe adverse events rate within the procedure
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01940406
Brief Title
The Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study
Official Title
The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Internal desicions
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BlueWind Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Parkinson Disease
Keywords
Essential Tremor, Parkinson Disease, Electrical Stimulation, Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulation procedure
Arm Type
Experimental
Arm Description
Stimulation procedure
Intervention Type
Procedure
Intervention Name(s)
Stimulation procedure
Intervention Description
Device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Improvement in tremor symptoms during the procedure
Description
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
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Giorini Silfen, PhD
Organizational Affiliation
BlueWind Medical
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurology, Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study
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