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 — OTHER
    DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude
  • Continuous + High Frequency Cycling — OTHER
    DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz
  • High Frequency — OTHER
    DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude
  • Microburst — OTHER
    DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet
  • Scheduling — OTHER
    DBS setting: Two or three effective programs on alternating schedules
  • Cycling — OTHER
    DBS 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 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.

Primary Outcome Measure

The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS) [ Time Frame: 3-Month post programming ]

Central Contacts

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