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Deep Brain Stimulation
A Clinical Evaluation of the ANS Totally Implantable Deep Brain Stimulation System for the suppression of tremor in the Upper Extremities of Patient with Essential Tremor
Principal Investor:
R. Malcolm Stewart, M.D.
Co-Investigators:
Mahdavi Thomas, M.D.
Michael Desaloms, M.D.
Elizabeth Peckham, D.O.
This clinical trial studies the effectiveness and safety of a new deep brain stimulation system in the treatment of essential tremor. All study participants will have the study device surgically implanted.
Eligibility Criteria (this is not a comprehensive list)
Inclusion criteria:
- Person is 18 to 80 years of age
- Person is diagnosed with essential tremor for at least 3 years
- Person has a disabling, treatment resistant upper extremity tremor not related to central nervous system disease or injury
- Person has tremor not adequately controlled by medications for at least three (3) months before implant
- Person must be willing to maintain a constant dose of anti-tremor medication for at least one month prior to study enrollment
- Person must be available for appropriate follow-up for the length of the study
Exclusion criteria:
- Person is not a surgical candidate
- Person has any major illness or medical condition that would interfere with participation in the study
- Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
- Person has untreated clinical significant depression
- Person has dementia
- Person has history of seizures
To learn more, call 1-800-725-2732.
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