Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS
NCT07302867 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-12-24
Summary
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.
Conditions
Interventions
- OTHER
-
Continuous
DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
- OTHER
-
Continuous + High Frequency Cycling
DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
- OTHER
-
High Frequency
DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
- OTHER
-
Microburst
DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
- OTHER
-
Scheduling
DBS setting: Two or three effective programs on alternating schedules
- OTHER
-
Cycling
DBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation
Sponsors & Collaborators
-
Boston Scientific Corporation
collaborator INDUSTRY -
University of British Columbia
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2028-01-01
- Completion
- 2028-04-01
Countries
- Canada
Study Locations
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