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

NCT07526155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Essential Tremor (ET)

Interventions

DEVICE

Deep Brain Stimulation (DBS)

Bilateral implantation of octopolar DBS leads covering VIM and PSA

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • European Regional Development Fund

    collaborator OTHER

  • Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

    lead OTHER

Principal Investigators

  • Majed Jouma Katati, PhD · Department of Surgery, Faculty of Medicine, Granada University (Granada, Spain). Department of Neurosurgery, Virgen de las Nieves University Hospital (Granada, Spain)

  • Francisco Escamilla Sevilla · Department of Neurology, Virgen de las Nieves University Hospital (Granada, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2023-12-20
Completion
2024-07-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526155 on ClinicalTrials.gov