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NCT Number: NCT07302867

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

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location contact

Christopher R Honey

PRINCIPAL_INVESTIGATOR

Danielle A Pietramala

CONTACT

[email protected]

604-875-4111 ext. 68396

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 3-Month post programming

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle A Pietramala

CONTACT

[email protected]

604-875-4111 ext. 68396

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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