Neuromodulation Strategies for Treatment-Resistant Essent... | NCT07302867

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

NCT07302867

Sponsor

University of British Columbia

Status

Not yet recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Essential Tremor

Interventions

Continuous
Continuous + High Frequency Cycling
High Frequency
Microburst
Scheduling
Cycling

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Neuromodulation in Treatment Resistant Essential Tremor in Early Habituation - Investigating Low and High Frequencies / Waveform Shaping / Pulse and Bursts / Combination Therapy in Deep Brain Stimulation Utilizing the Boston Scientific® Chronos™ Software

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Jan 1, 2028Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Dec 11, 2025

First Submission Date that Met QC Criteria

Dec 11, 2025

First Posted Date

Dec 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Honey, Principal Investigator, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous	Other	DBS setting: 185 Hz, 60 µs pulse width, optimized amplitude	Single Experimental Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS)		3-Month post programming

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Danielle A Pietramala	Contact	604-875-4111	68396	danielle.pietram@ubc.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital		Vancouver	British Columbia	V5Z1M9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020329	Essential Tremor

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001071	Appointments and Schedules

Ancestor Terms

ID	Term
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.