Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06813300

Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024

Led by Centre Hospitalier St Anne · Updated on 2025-02-06

250

Participants Needed

2

Research Sites

605 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. In recent years, new indications have been studied for severe and drug-resistant forms of several neurological and neuropsychiatric pathologies. Its non-lesional, reversible and customizable nature make it a therapy of choice. However, several factors are currently slowing down the evolution and optimization of SCP. The identification of objective, quantifiable and predictive criteria for the therapeutic effects of stimulation would allow an acceleration of the individualized identification of the therapeutic parameters of SCP. The surgical procedure for implanting the stimulation equipment is carried out in several stages, which offer unique opportunities to acquire individual imaging or electrophysiology data that are potentially predictive of the therapeutic effect of DBS. In order to continue the optimization of DBS procedures, and therefore to maximize its therapeutic effects, it seems crucial to us to take advantage of all the neurophysiological data likely to be collected during this procedure. Furthermore, given the multiplication of indications for SCP, it seems necessary to highlight specific markers. Thus, the use of neurocognitive and/or motor tests specific to each pathology and coupled with electrophysiological recordings and anatomical and functional examinations would make it possible to highlight specific functional biomarkers predictive of therapeutic effects.

CONDITIONS

Official Title

Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • Patient suffering from a pathology requiring treatment with deep brain stimulation: neurological disease (e.g.: Parkinson Disease, Essential Tremors, dystonia, epilepsy, etc.) or psychiatric disease (e.g.: Obsessive Compulsive Disorder, depression, eating disorders, etc.)
  • Patient capable of understanding the study procedures and completing the self-questionnaires in French
  • Patient informed and having signed the informed consent form
Not Eligible

You will not qualify if you...

  • Contraindications to DBS, neurosurgery or anesthesia
  • Patients with significant hemorrhagic or infectious risks
  • Patient unable to perform the neurocognitive or sensorimotor tests
  • Patient who is not a beneficiary of a social security system

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Grenoble-Alpes Hospital Center

Grenoble, France, 38043

Not Yet Recruiting

2

Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris

Paris, France, 75014

Actively Recruiting

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Research Team

P

Philippe Domenech, Professor, MD, PhD

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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Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024 | DecenTrialz