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Essential Tremor (ET)NCT07526155

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

A study testing Deep Brain Stimulation (DBS) in people with Essential Tremor (ET), run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Tremor (ET)
What is being tested?
Deep Brain Stimulation (DBS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteSpain
Study dates
27 May 2020to 24 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Granada, Granada, 18013

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Deep Brain Stimulation (DBS)
Keywords
Essential tremor, Deep brain stimulation, Posterior subthalamic area, Ventral intermediate nucleus
Medical subject headings
Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain Stimulation (DBS)Device

    Bilateral implantation of octopolar DBS leads covering VIM and PSA

Study groups in NCT07526155
Study groupRoleWhat they receive
VIM-DBSActive comparatorStimulation delivered to VIM
Receives: Device: Deep Brain Stimulation (DBS)
PSA-DBSExperimentalStimulation delivered to PSA
Receives: Device: Deep Brain Stimulation (DBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: - 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)

  1. Stimulation efficiency assessed by stimulation amplitudes (mA)

    Stimulation efficiency measured by stimulation amplitudes (mA). The greater the amplitude, the higher the energy consumption (lower theoretical energy efficiency)

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

  2. Stimulation efficiency measured by total electrical energy delivered (TEED)

    TEED (μJ) = [(I² · R · PW · f) 1e-6], where DBS parameters are frequency (f, Hz), pulse width (PW, μsec), impedance (R, Ω) and current intensity (I, mA).

    The higher the TEED, the lower the energy efficiency.

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

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

    Change from baseline to the end of the VIM-DBS vs PSA-DBS period assessed using VAS-QoL (1-10; higher scores indicate better QoL)

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

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

    Change from baseline to the end of the VIM-DBS vs PSA-DBS period assessed using the QUEST (1-120; higher scores indicate poor QoL)

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

  5. Number and type of stimulation-induced side effects

    Type and frequency (absolute and relative) of stimulation-induced side effects in the VIM-DBS vs PSA-DBS period

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

  6. Overall cognitive assessment evaluated using the Dementia Rating Scale 2 (DRS-2)

    Change in cognition from baseline to the end of the VIM-DBS vs PSA-DBS period assessed using the DRS-2 (1-144; higher scores indicate better cognitive performance)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start27 May 2020
  3. Primary completion20 Dec 2023
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07526155
Sponsor's protocol ID
PI19/01571
Status last verified
Apr 2026
First submitted
20 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data are not publicly available due to the risk of breached patient confidentiality

Publications

  • 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.

    PubMed 29970404

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation (DBS) in people with Essential Tremor (ET), run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in tremor assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTM-TRS) total score (time frame: - Preoperative baseline, - 4 postoperative months (after the first 3-month stimulation period) and - 7 postoperative months (after the second 3-month stimulation period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07526155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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