Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05671848

Electroclinical Correlates in Essential Tremor

Led by University Hospital, Bordeaux · Updated on 2024-11-01

10

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

M

MINDig

Collaborating Sponsor

AI-Summary

What this Trial Is About

Essential tremor (ET) is a neurological disorder that affects nearly 0.9% of the world's population. High-frequency Deep Brain Stimulation (DBS) of the ventral-intermediate nuclei of the thalamus (VIM) has been proven as an effective second-line treatment for severe forms of ET. The arrival on the market of the PERCEPT™ (new stimulator/recorder, Medtronic, Minneapolis, USA) now allows, in addition to the stimulation delivery, the recording of intracerebral activity at a distance from surgery, in a non-invasive way and in ecological condition at home. Investigators aim at recording the variations of thalamic Local Field Potentials (LFP) oscillations, in ecological condition, during rest and movement, with and without deep brain stimulation, once a week, between M3 and M6 post surgery.

CONDITIONS

Official Title

Electroclinical Correlates in Essential Tremor

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced disabling and drug-resistant tremor
  • Receiving deep brain stimulation treatment with implantation of the PERCEPT12 device according to standard care
  • Chronic progressive cardiac, renal, hematological or pulmonary diseases under treatment
  • Patient aged between 18 to 75 years
  • Normal brain MRI
  • MATTIS score 9 130/144 or MOCA 9 24/30
  • Subject affiliated with or benefiting from a social security plan
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
Not Eligible

You will not qualify if you...

  • Major depressive syndrome (Beck scale > 20)
  • MRI showing significant brain atrophy or significant hypersignals
  • Pregnant or breastfeeding women
  • Being unable to give personal consent
  • Be subject to a measure of legal protection (curatorship, guardianship) or placed under judicial protection.

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Bordeaux

Bordeaux, France, 33076

Actively Recruiting

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Research Team

E

Edouard COURTIN, Dr

CONTACT

O

Olivier Branchard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Electroclinical Correlates in Essential Tremor | DecenTrialz