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

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

Overview

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.

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

Primary outcome measures

• The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS) [Time frame: 3-Month post programming]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Vancouver General Hospital — Vancouver

Identifiers

NCT: NCT07302867 · H25-03800

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗