Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS (NCT07302867) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuromodulation Strategies for Treatment-Resistant Essential Tremor Using Chronos™ DBS
Canada5 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
19 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called the Chronos™ DBS system for essential tremor — how does this device differ from the DBS systems already approved for tremor, and what does that mean for what's known about its safety?
2The trial is listed as 'not yet recruiting' — given where I am in my treatment journey right now, would it make sense to wait for this study to open, or should we be pursuing other options in the meantime?
3Since this is listed as Phase NA, can you help me understand what stage of testing this technology is actually at, and how that affects what researchers do and don't yet know about how well it works?
4The main thing this trial is measuring is something called the Fahn-Tolosa-Marín Tremor Rating Scale — can you walk me through what that actually tests, and whether the changes it would measure would be meaningful for my daily life?
5Before I consider a surgical approach like deep brain stimulation in a trial setting, are there medication or other non-surgical options I haven't tried yet that might be worth exhausting first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Fahn-Tolosa-Marín Tremor Rating Scale (FTM-TRS)