Clinical trial for Essential Tremor
Official title Directional Bilateral Thalamic Patterned Stimulation (Chronos)
ClinicalTrials.gov ID: NCT06325852
What this study is testing
- What it's testing
- The study will find the best stimulation settings and see if the new device is safe and helps reduce tremors in patients with essential tremor.
- Who it's for
- Adults with essential tremor who either need deep‑brain‑stimulation surgery or have had it before but lost benefit.
- What's involved
- Participants will have two new directional leads implanted in the brain and will use a Boston Scientific pulse generator. They will visit the clinic for programming, follow‑up visits, and tremor tests.
- Time commitment
- The study lasts about 12 months, with regular clinic visits for programming and safety checks, plus a final follow‑up at the end of the study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Phase 1: 5 to 10 tremor patients already treated with VIM-DBS but not doing well due to early and/or late loss of benefits (i.e.
- Phase 2: 10 Essential Tremor patients in need of DBS surgery.
- Written and signed Informed Consent.
- Age 18 to 85 years old.
- Subject must have Essential Tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral action tremor
You likely can't join if
- Unwilling or inability to follow the procedures specified by the protocol.
- Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study...
- Untreated clinically significant depression.
- Any current drug or alcohol abuse, as determined by the investigator.
- History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator.
- Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
See the full eligibility criteria
- Phase 1: 5 to 10 tremor patients already treated with VIM-DBS but not doing well due to early and/or late loss of benefits (i.e.
- Phase 2: 10 Essential Tremor patients in need of DBS surgery.
- Written and signed Informed Consent.
- Age 18 to 85 years old.
- Subject must have Essential Tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral action tremor; (b) at least three years duration
- Soft signs (categorizing patients as Essential Tremor-plus) will be allowed and noted in the patient's chart.
- Subject must be on stable dose of anti-tremor medication for at least 4 weeks prior to screening.
- Subject had no botulinum injection for at least three months prior to screening.
- Subject does not have a significant other medical condition biasing the study finding in investigator's opinion.
- Unwilling or inability to follow the procedures specified by the protocol.
- Presence of significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol.
- Untreated clinically significant depression.
- Any current drug or alcohol abuse, as determined by the investigator.
- History of suicidal attempt within the last 1 year prior to consent or current active suicidal ideation as determined by the investigator.
- Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Any terminal illness with life expectancy of \< 12 months.
- Participation in any other treatment clinical trial (e.g. drug, device).
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.