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Not yet recruitingNCT07302867Updated Dec 24, 2025

Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS

An interventional study of Continuous and Continuous + High Frequency Cycling in Essential Tremor, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
19 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description
  • Purpose: To test whether new DBS programming patterns can restore and sustain tremor control in essential tremor (ET) patients who lose benefit quickly after standard Vim-DBS.
  • 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.
02

Conditions studied

  • Essential Tremor

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Keywords

  • Deep Brain Stimulation
  • Essential Tremor
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 5 is below the median of 25 across 189 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with essential tremor who have undergone standard Vim-DBS surgery
  • Demonstrated rapid (early) habituation to standard programming.
  • Ability to provide and attend follow-up visits.

Exclusion criteria

Exclusion Criteria:

  • Inability to attend programming visits.
  • Cognitive or language impairment precluding consent.
  • Other neurological conditions confounding tremor assessment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study 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.

    Other: Continuous · Other: Continuous + High Frequency Cycling · Other: High Frequency · Other: Microburst · Other: Scheduling · Other: Cycling

Interventions

  • OtherContinuous

    DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude

  • OtherContinuous + High Frequency Cycling

    DBS setting: Alternates 30s at 185 Hz and 30s at 1000 Hz

  • OtherHigh Frequency

    DBS setting: 1000 Hz continuous, 60 µs, optimized amplitude

  • OtherMicroburst

    DBS setting: 900 Hz intraburst, 80 Hz interburst, 6 pulses per packet

  • OtherScheduling

    DBS setting: Two or three effective programs on alternating schedules

  • OtherCycling

    DBS setting: 30s on / 5s off cycle without ramp, subthreshold stimulation

06

What researchers measure

Primary outcomes

  1. The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS)

    Time frame: 3-Month post programming

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07302867
Responsible party
Christopher Honey (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Dec 24, 2025
Start date
Apr 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Dec 24, 2025

Study contacts

Danielle A Pietramala
Contact
danielle.pietram@ubc.ca
604-875-4111 ext. 68396

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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