Deep Brain Stimulation for Essential Tremor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new programming method for Deep Brain Stimulation (DBS) using the Chronos™ DBS system can assist individuals with essential tremor (ET) who no longer benefit from standard DBS treatment. Researchers will test six different stimulation settings to identify any that improve tremor symptoms more effectively than the standard treatment. Ideal participants are adults with ET who have undergone DBS surgery but experienced a rapid decline in tremor benefits. Participants will try various DBS settings in the clinic, use one setting at home, and attend follow-up visits to monitor progress. As an unphased trial, this study provides a unique opportunity to explore innovative DBS programming for those seeking improved tremor management.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this new DBS programming method is safe for essential tremor patients?
Studies have shown that deep brain stimulation (DBS) for essential tremor is generally well-tolerated. Research on patients with essential tremor who received DBS on both sides of the brain indicates it is safe for most people. When previous DBS settings became less effective, researchers tested new stimulation patterns using a software called Chronos™.
Although specific safety data for Chronos™ is limited, the existing use of DBS for essential tremor suggests it is generally safe. Participants in earlier studies did not report any major safety concerns. However, like any medical treatment, some side effects might occur, such as mild discomfort or temporary changes in mood or thinking.
Overall, while past DBS use shows promising safety evidence, participants should discuss any concerns with their doctors.12345Why are researchers excited about this trial?
Researchers are excited about Chronos™ DBS for essential tremor because it offers a personalized approach to deep brain stimulation. Unlike traditional DBS systems, which usually rely on fixed settings, Chronos™ allows for customizable stimulation programs tailored to an individual’s specific needs. This adaptability aims to improve tremor control while minimizing side effects, potentially offering a more efficient and effective management of symptoms compared to standard treatments like medication or conventional DBS devices.
What evidence suggests that this new DBS programming is effective for essential tremor?
Research has shown that traditional Deep Brain Stimulation (DBS) for essential tremor (ET) may become less effective over time, with a 50% improvement in tremors observed after one year. However, advanced DBS programming offers hope. In this trial, participants will test six different experimental DBS stimulation programs using Chronos™ software. These new methods change the delivery of stimulation to better control tremors. Early results suggest that different settings might help regain tremor control in patients who no longer benefit from standard DBS. This approach is being tested to determine if it can provide longer-lasting improvement for people with ET.12678
Are You a Good Fit for This Trial?
This trial is for adults with essential tremor who no longer respond to standard Deep Brain Stimulation (DBS) therapy. Only 5 participants will be included, and they must have experienced a quick loss of benefit after receiving standard VIM-DBS treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete a clinic visit to try six different DBS stimulation settings using specialized Chronos software and are randomly assigned to one setting for home use
Follow-up
Participants receive a follow-up phone call at 4 weeks to check on symptoms and device use, and return to the clinic at 3 months for a full tremor evaluation
Optional Long-term Follow-up
Participants have the option to return for an additional follow-up visit at 1 year
What Are the Treatments Tested in This Trial?
Interventions
- Chronos™ DBS
Trial Overview
The study tests new DBS programming methods using the Chronos system in patients with essential tremor. It compares six different stimulation settings to see if they can restore and maintain tremor control better than the standard approach.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Citations
NCT07302867 | Neuromodulation Strategies for Treatment ...
The goal of this observational study is to learn whether a new way of programming Deep Brain Stimulation (DBS) can improve and maintain tremor ...
Deep Brain Stimulation for Tremor: Update on Long-Term ...
However, Vim-DBS efficiency reduces over time, with total tremor scores showing a 55–65% improvement at 6 months, 53–66% improvement at 12 months, 50% ...
Directional Bilateral Thalamic Patterned Stimulation ...
Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/a1186edde455c7fe/nct07302867-neuromodulation-treatment-resistant-essential-tremor-deep-brain-stimulationNeuromodulation Strategies for Treatment-Resistant Essential ...
Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no ...
Long-term effects of deep brain stimulation for essential ...
Results: Twenty-six patients responded, with a median follow-up of 41 months. Approximately half of the patients had more than 48 months of follow-up. At the ...
Proceedings of the 10th annual deep brain stimulation think tank
Automated deep brain stimulation programming with safety constraints for tremor suppression in patients with Parkinson's disease and essential tremor. J ...
7.
ctv.veeva.com
ctv.veeva.com/study/neuromodulation-strategies-for-treatment-resistant-essential-tremor-using-chronos-dbsNeuromodulation Strategies for Treatment-Resistant Essential ...
Researchers will compare six different stimulation settings to see if any of them can improve tremor symptoms when standard DBS programming no ...
DBS Programming for Essential Tremor
Research has shown that deep brain stimulation (DBS) on both sides of the brain for essential tremor is generally well-tolerated. One study found that this ...
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