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COMPLETED
NCT07526155
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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