Interphase Gap in Biphasic Stimulation in DBS for ET (NCT05177900) | Clinical Trial Compass
CompletedNot Applicable
Interphase Gap in Biphasic Stimulation in DBS for ET
Belgium9 participantsStarted 2021-12-01
Plain-language summary
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.
Who can participate
Age range
18 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:
* Patients with essential tremor treated with Vim-DBS
* Normal impedances of DBS circuit
* Signed written informed consent
Exclusion Criteria:
* Active psychiatric disease or active alcohol or drug abuse
* Dementia
* History of recurrent or unprovoked seizures
* Relevant comorbidities that influence objective clinical assessment
* Pregnancy
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Therapeutic threshold (mA)
Timeframe: During uptitration of the amplitude (entire process takes 3-4 minutes)
2
Side effect threshold (mA)
Timeframe: During uptitration of the amplitude (entire process takes 3-4 minutes)