BridgeMD
New treatment option for Essential Tremor
Official title Directional Bilateral Thalamic Patterned Stimulation (Chronos)
ClinicalTrials.gov ID: NCT06325852
What this study is testing
- What it's testing
- Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery.
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. tremor scores ON...
- 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)...
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. tremor scores ON stimulation identical or greater than before surgery in absence of...
- 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; and (c) with or without tremor in...
- 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's taking place
- 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 - 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?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.