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

NCT06813300 | Recruiting

• 1 other identifier: D24-P005
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Pathology Requiring Deep Brain Stimulation Therapy

Keywords

DBS; LFP; MUA; MEG; IRM; cognitive tasks

Outcome Measures

Primary Outcomes (2)

• Brain activity recorded by electrophysiological measurements

  Electrophysiological variables recorded during neurocognitive and/or sensorimotor tests before and after the DBS procedure (at least 2 months at effective parameters)

  From enrollment through study completion, an average of 2 years

• Therapeutic effectiveness of DBS

  The effectiveness of DBS is calculated as the differential (in %) of the symptom severity score(s) before and after the DBS procedure, measured using scales specific to each pathology (e.g. MADRS for depression (min score: 0 - max score: 60), YBOCS for OCD (min score: 0- max score: 40). Higher score means worse outcome for both scales.

  From enrollment through study completion, , an average of 2 years

Secondary Outcomes (4)

• Number of patients with pre operative MRI by intensity

  Day - 21

• Therapeutic effectiveness of DBS

  From enrollment through study completion, an average of 2 years

• Number of participants with correct DBS electrodes implantation

  Day 0

• Number of participants with inter-individual reproducibility of electrophysiological responses

  From enrollment to the end of study at 18 months

Study Arms (1)

Cognitive tasks performed during electrophysiological recordings

EXPERIMENTAL

Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS

Procedure: Electrophysiological recordings

Interventions

Electrophysiological recordings PROCEDURE

Addition of electrophysiological recordings performed during cognitive tasks passation in patients undergoing DBS: in pre-op, per-op, peri-op and post-op setting

Cognitive tasks performed during electrophysiological recordings

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (2)

Grenoble-Alpes Hospital Center

Grenoble, 38043, France

NOT YET RECRUITING

Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris

Paris, 75014, France

RECRUITING

Central Study Contacts

Philippe Domenech, Professor, MD, PhD

CONTACT

0033(0)149812201; philippe.domenech@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: February 6, 2025
• Study Start: September 18, 2024
• Primary Completion (Estimated): April 25, 2036
• Study Completion (Estimated): April 25, 2036
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)