Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS
NCT ID: NCT07302867
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
5 participants
INTERVENTIONAL
2026-04-01
2028-04-01
Brief Summary
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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.
Detailed Description
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* Hypothesis: Novel stimulation paradigms - like high-frequency, microburst, cycling, and scheduling - can overcome early habituation and provide lasting tremor improvement.
* Justification: Some ET patients experience rapid loss of benefit despite correct DBS placement. Standard programming does not help them, creating a disabling condition. Advanced programming may offer a safe, non-surgical solution.
* Objectives:
* 1\. Determine if Chronos™ software programs maintain tremor improvement beyond one month.
* 2\. Assess safety, tolerability, and identify the most effective stimulation parameters.
* Research Design: Prospective, single-center cohort study of 5 early-habituating ET patients. Patients trial six stimulation paradigms in clinic, then are randomized to one program for home use. Follow-up occurs at 4 weeks, 3 months, and optionally 1 year.
* Statistical Analysis: Descriptive statistics due to small sample size. Outcomes include tremor ratings, patient-reported benefit, and recurrence of habituation.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Experimental Arm
All 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.
Continuous
DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
Continuous + High Frequency Cycling
DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
High Frequency
DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
Microburst
DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
Scheduling
DBS setting: Two or three effective programs on alternating schedules
Cycling
DBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation
Interventions
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Continuous
DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
Continuous + High Frequency Cycling
DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
High Frequency
DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
Microburst
DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
Scheduling
DBS setting: Two or three effective programs on alternating schedules
Cycling
DBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation
Eligibility Criteria
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Inclusion Criteria
* Demonstrated rapid (early) habituation to standard programming.
* Ability to provide informed consent and attend follow-up visits.
Exclusion Criteria
* Cognitive or language impairment precluding consent.
* Other neurological conditions confounding tremor assessment.
19 Years
85 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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Christopher Honey
Principal Investigator
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Danielle A Pietramala
Role: primary
Other Identifiers
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H25-03800
Identifier Type: -
Identifier Source: org_study_id