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

NCT07526155 | Completed

• 1 other identifier: PI19/01571
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Essential tremor; Deep brain stimulation; Posterior subthalamic area; Ventral intermediate nucleus

Outcome Measures

Primary Outcomes (1)

• Improvement in tremor assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) total score

  Improvement from baseline to the end of the VIM-DBS vs PSA-DBS period, assessed as the FTM-TRS total score (0-144 points; higher scores indicate greater tremor severity).

  - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)

Secondary Outcomes (6)

• Stimulation efficiency assessed by stimulation amplitudes (mA)

  4 postoperative months (after the first 3-month stimulation period) and 7 postoperative months (after the second 3-month stimulation period)

• Stimulation efficiency measured by total electrical energy delivered (TEED)

  4 postoperative months (after the first 3-month stimulation period) and 7 postoperative months (after the second 3-month stimulation period)

• Quality of life (QoL) assessed using Visual Analog Scale (VAS)

  - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)

• Quality of life (QoL) assessed using the Quality of life in essential tremor questionnaire (QUEST)

  - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)

• Number and type of stimulation-induced side effects

  - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)

Study Arms (2)

VIM-DBS

ACTIVE COMPARATOR

Stimulation delivered to VIM

Device: Deep Brain Stimulation (DBS)

PSA-DBS

EXPERIMENTAL

Stimulation delivered to PSA

Device: Deep Brain Stimulation (DBS)

Interventions

Deep Brain Stimulation (DBS) DEVICE

Bilateral implantation of octopolar DBS leads covering VIM and PSA

PSA-DBS; VIM-DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos III Health Institute: collaborator
• European Regional Development Fund: collaborator
• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead

Study Sites (1)

Virgen de las Nieves University Hospital (Neurotraumatology and Rehabilitation Hospital)

Granada, Granada, 18013, Spain

Location

Related Publications (1)

• Barbe MT, Reker P, Hamacher S, Franklin J, Kraus D, Dembek TA, Becker J, Steffen JK, Allert N, Wirths J, Dafsari HS, Voges J, Fink GR, Visser-Vandewalle V, Timmermann L. DBS of the PSA and the VIM in essential tremor: A randomized, double-blind, crossover trial. Neurology. 2018 Aug 7;91(6):e543-e550. doi: 10.1212/WNL.0000000000005956. Epub 2018 Jul 3.

  PMID: 29970404 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Francisco Escamilla Sevilla

  Department of Neurology, Virgen de las Nieves University Hospital (Granada, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigadora colaboradora, doctoranda.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 13, 2026
• Study Start: May 27, 2020
• Primary Completion: December 20, 2023
• Study Completion: July 24, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)