Clinical Trial to Compare VIM vs PSA Bilateral Deep Brain Stimulation in Patients With Essential … (NCT07526155) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Compare VIM vs PSA Bilateral Deep Brain Stimulation in Patients With Essential Tremor
Spain11 participantsStarted 2020-05-27
Plain-language summary
Deep brain stimulation (DBS) of both ventral intermediate nucleus (VIM) and the posterior subthalamic area (PSA) has shown to be an effective treatment for essential tremor (ET). Characterizing the differences between both targets is necessary. The aim of the study is comparison of efficacy, safety, energy efficiency, neuropsychological status and quality of life of bilateral PSA-DBS vs bilateral VIM-DBS in the treatment of ET. The study hypothesis is that PSA-DBS is not inferior to VIM-DBS in terms of efficacy in controlling tremor, but has superior energy efficiency and safety.
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:
* Confirmed diagnosis of bilateral ET or ET-plus according to the Movement Disorders Society criteria.
* Refractoriness to medication: at least two attempts at medical treatment with at least two groups of different medication (fundamentally propranolol and primidone), which were ineffective (insufficient tremor control or adverse effects).
* Subjects of both sexes, older than 18 years old.
* Sufficient competence to collaborate and comply with the study protocols.
* Ability to provide informed consent.
Exclusion Criteria:
* Clinically relevant cognitive decline which may interfere with the study.
* Clinically relevant active psychiatric disorder.
* Contraindication for general surgery or bilateral DBS.
* Unsuitable electrode location according to neuroimaging.
* Participation in other interventional study.
* Cerebral atrophy (width of the third ventricle \>10 mm) or other anatomical anomalies that would interfere with optimal stereotactic localization.
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
Improvement in tremor assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) total score
Timeframe: - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)
Trial details
NCT IDNCT07526155
SponsorFundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental