Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02947841 : The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients with clinically diagnosed ET who have had placement of VIM DBS and are
willing to undergo a baseline programming visit and 12-week follow-up assessment

2. At least initial benefit from VIM DBS as judged by patient report and clinician exam

3. VIM DBS placement no less than three months from entry into study

4. Patients must demonstrate ability to use patient programmer to switch between group
settings on a weekly basis

5. Ability to wear wrist monitor for 2 week intervals, twice during the study 6.
Patients with the following IPG types: Activa PC, SC or RC

Exclusion Criteria:

1. Atypical tremor disorder including but not limited to tremor due to multiple
sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome

2. DBS placement complicated by infection, hemorrhage or stroke

3. Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or
previous DBS surgery resulting in explantation and reimplantation

4. Known incorrect or poor lead placement

5. Inability to change group settings on a weekly basis at least 75% of the time

6. Inability to tolerate 12-week period without additional programming changes,
including voltage stimulation adjustment

7. Inability to tolerate 12-week period without adjustment of anti-tremor medications,
including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines

8. Battery voltage < or equal to 2.70V

9. Patient with the following IPG types: Soletra, Kinetra or Itrel

10. Inability to tolerate two group settings due to side effects or lack of efficacy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02947841      |      Link to official Clinicaltrials.gov listing
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