Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS
- Sponsor
- University of British Columbia
- Study ID
- NCT07302867
- Status
- Not Yet Recruiting
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Conditions
- Essential Tremor
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Continuous — OTHERDBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
- Continuous + High Frequency Cycling — OTHERDBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
- High Frequency — OTHERDBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
- Microburst — OTHERDBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
- Scheduling — OTHERDBS setting: Two or three effective programs on alternating schedules
- Cycling — OTHERDBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation
Study Details
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor control in adults with essential tremor (ET) who stopped responding to standard DBS therapy. The main questions it aims to answer are: * 1\. Can advanced DBS settings, using varied stimulation patterns, frequencies, and pulses, restore tremor control in people with ET who lost benefit from standard Ventral Intermedius Deep Brain Stimulation (VIM-DBS)? * 2\. Do these advanced settings provide more stable, longer-lasting tremor improvement over time? Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no longer works. Participants will: * Complete a clinic visit where they try six different DBS stimulation settings using specialized Chronos software. * Be randomly assigned to one of these settings to use at home. * Receive a follow-up phone call at 4 weeks to check on symptoms and device use. * Return to the clinic at 3 months for a full tremor evaluation. * Have the option to return for an additional follow-up visit at 1 year. This study will include 5 participants with essential tremor who previously lost benefit quickly after receiving standard VIM-DBS treatment.
Key Dates
- First listed
- Dec 24, 2025
- Start date
- Apr 1, 2026
- Status verified
- Dec 2025
- Primary completion
- Jan 1, 2028
- Completion
- Apr 1, 2028
Study Design
- Enrollment
- 5 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single Experimental ArmAll participants will test six different experimental DBS stimulation programs in the clinic using Chronos™ software. After trying all six programs, each participant will be randomly assigned to one of the six stimulation patterns to use at home for the study period. There is no control or placebo group; all participants receive an active DBS programming intervention.
Primary Outcome Measure
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS) [ Time Frame: 3-Month post programming ]
Central Contacts
- Danielle A Pietramala604-875-4111
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