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

No results posted yet for this 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.

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302867 on ClinicalTrials.gov