NCT07526155

Clinical Trial to Compare VIM vs PSA Bilateral Deep Brain Stimulation in Patients With Essential Tremor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Deep brain stimulation (DBS) of the ventral intermediate (VIM) nucleus of the thalamus is an effective treatment for disabling essential tremor (ET). In recent years, the posterior subthalamic area (PSA) has emerged as a potentially more effective target. There is a need for specific research into the clinical efficacy, efficiency, as well as the mid-term cognitive and quality-of-life outcomes of VIM-DBS and PSA-DBS. The aim of this study is: 1) to compare the efficacy and safety of bilateral PSA-DBS versus bilateral VIM-DBS in the treatment of ET. 2) to determine the impact of bilateral PSA-DBS versus bilateral VIM-DBS on quality of life, neuropsychological status, energy efficiency of the DBS system, and durability of the tremor-suppressing effect. The 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. To this end, a randomized, double-blind, crossover trial will be conducted, in which bilateral octopolar DBS leads will be implanted in a single-trajectory covering the VIM and PSA in patients with disabling and refractory ET. They will be randomly assigned to group 1 (PSA-VIM) or group 2 (VIM-PSA), undergoing stimulation on each target for 3 months. A blinded assessment will be carried out at the end of each period.

Conditions

• Essential Tremor (ET)

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation (DBS)	Bilateral implantation of octopolar DBS leads covering VIM and PSA

Timeline

• Start date: 2020-05-27
• Primary completion: 2023-12-20
• Completion: 2024-07-24
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Spain