Directional Bilateral Thalamic Patterned Stimulation (Chronos) (NCT06325852)
Directional Bilateral Thalamic Patterned Stimulation in Individuals with Essential Tremor
🩺 Plain-English Summary (8th-Grade Level)
Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads. Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor. Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.
Who can join: Review the eligibility criteria below.
Location: Movement Disorders Centre - Toronto Western Hospital — Toronto, Ontario
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
- DBS programing (OTHER)
📋 "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)
- Movement Disorders Centre - Toronto Western Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 603-5800
Email: alfonso.fasano@uhn.ca
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.