Clinical trial: The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients (NCT02947841)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment