Circadian Adaptive DBS in Essential Tremor (NCT06635811)
Circadian Adaptive Deep Brain Stimulation in Essential Tremor
🩺 Plain-English Summary (8th-Grade Level)
Deep brain stimulation (DBS) of the thalamus is an effective treatment for medically refractory essential tremor (ET). DBS involves delivering continuous stimulation to the brain through electrodes permanently implanted in the thalamus. Despite proven effectiveness, the long-term benefit of DBS can wane over time (habituation) and side effects, including paresthesia and dysarthria, often limit the amplitude of the stimulation, resulting in suboptimal control of tremor. In clinical practice, many groups advise patients to switch their devices off at night to avoid habituation and reduce side effects. However, manually turning off the device at night can result in uncontrolled tremor when the patient moves at night. This study aims to develop an algorithm that automatically turns off stimulation when a patient is asleep, based on circadian brain signals. Turning off stimulation could potentially improve the therapy by limiting adverse effects, increasing efficacy, reducing the risk of habituation, and prolonging battery life. This study will evaluate the feasibility, safety, and tolerability of circadian adaptive DBS.
Who can join: Review the eligibility criteria below.
Location: Norman Fixel Institute for Neurological Diseases — Gainesville, Florida
Age range: 21 Years to 89 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Norman Fixel Institute for Neurological Diseases — Gainesville, Florida
📞 Contact the Study Coordinator
Phone: (352) 265-0111
Email: Julia.Gonzalez@neurology.ufl.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Essential Tremor
- Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study — Rochester, Minnesota
- Bilateral Treatment of Medication Refractory Essential Tremor — Stanford, California
- Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET) — Morgantown, West Virginia
- RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease — Birmingham, Alabama
- Responsive Deep Brain Stimulator for Essential Tremor — Gainesville, Florida
- Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders: — Stanford, California
Explore by condition: All Essential Tremor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.