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Clinical Trial to Compare VIM vs PSA Bilateral Deep Brain Stimulation in Patients With Essential Tremor
Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
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.
Official title: Randomised, Double-Blind, Crossover Clinical Trial Comparing Bilateral Deep Brain Stimulation of the Posterior Subthalamic Area Versus the Ventral Intermediate Nucleus of the Thalamus in Essential Tremor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2020-05-27
Completion Date
2024-07-24
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Deep Brain Stimulation (DBS)
Bilateral implantation of octopolar DBS leads covering VIM and PSA
Locations (1)
Virgen de las Nieves University Hospital (Neurotraumatology and Rehabilitation Hospital)
Granada, Granada, Spain