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

Essential Tremor research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Essential Tremor

Parkinson Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Stimulation procedureDevice

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Stimulation procedureStimulation procedure

Study Status

Withdrawn

Start Date: October 2013

Completed Date: December 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The severe adverse events rate within the procedure

Secondary Outcome: Improvement in tremor symptoms during the procedure

Study sponsors, principal investigator, and references

Principal Investigator: Shirley Giorini Silfen, PhD

Lead Sponsor: Rainbow Medical

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01940406

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