Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pathology Requiring Deep Brain Stimulation Therapy
Keywords: DBS
LFP
MUA
MEG
IRM
cognitive tasks
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brain activity recorded by electrophysiological measurements
timeFrame: From enrollment through study completion, an average of 2 years
measure: Therapeutic effectiveness of DBS
timeFrame: From enrollment through study completion, , an average of 2 years
Secondary outcomes:
measure: Number of patients with pre operative MRI by intensity
timeFrame: Day - 21
measure: Therapeutic effectiveness of DBS
timeFrame: From enrollment through study completion, an average of 2 years
measure: Number of participants with correct DBS electrodes implantation
timeFrame: Day 0
measure: Number of participants with inter-individual reproducibility of electrophysiological responses
timeFrame: From enrollment to the end of study at 18 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble-Alpes Hospital Center
city: Paris
country: France
facility: Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris
Study officials:
References: