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 range18 Years

SexALL

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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.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-20