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

NCT07302867 | Not Yet Recruiting DMC

• 1 other identifier: H25-03800
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Essential Tremor

Keywords

Deep Brain Stimulation; Essential Tremor

Outcome Measures

Primary Outcomes (1)

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

  3-Month post programming

Study Arms (1)

Single Experimental Arm

EXPERIMENTAL

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

High Frequency OTHER

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

Single Experimental Arm

Cycling OTHER

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

Single Experimental Arm

Continuous OTHER

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

Single Experimental Arm

Continuous + High Frequency Cycling OTHER

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

Single Experimental Arm

Microburst OTHER

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

Single Experimental Arm

Scheduling OTHER

DBS setting: Two or three effective programs on alternating schedules

Single Experimental Arm

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to attend programming visits.
• Cognitive or language impairment precluding consent.
• Other neurological conditions confounding tremor assessment.

Sponsors & Collaborators

• University of British Columbia: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Central Study Contacts

Danielle A Pietramala

CONTACT

604-875-4111; danielle.pietram@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, single-center, single-group assignment interventional study. All enrolled participants undergo a structured trial of six experimental DBS stimulation paradigms delivered through Chronos™ software. Participants are then randomized to one stimulation program for at-home use. There is no comparison group; all participants receive active intervention. Follow-up occurs at 4 weeks, 3 months, and optionally at 1 year to assess tremor response, durability of benefit, and safety.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)