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

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.

Study Overview

• Status: Recruiting
• Conditions: Pathology Requiring Deep Brain Stimulation Therapy
• Intervention / Treatment: Procedure: Electrophysiological recordings

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Domenech, Professor, MD, PhD; Phone Number: 0033(0)149812201; Email: philippe.domenech@ghu-paris.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Not yet recruiting
    • Grenoble-Alpes Hospital Center
    • Contact: Mircea POLOSAN, MD
    • Contact: Mircea POLOSAN, MD; Phone Number: 0033 476765383; Email: MPolosan@chu-grenoble.fr
  • Paris, France, 75014
    • Recruiting
    • Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris
    • Contact: Khaoussou Sylla, MD, PhD; Phone Number: +33 1 45 65 76 78; Email: K.SYLLA@ghu-paris.fr
    • Contact: Philippe DOMENECH, Professor, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive tasks performed during electrophysiological recordings; Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS	Procedure: Electrophysiological recordings; Addition of electrophysiological recordings performed during cognitive tasks passation in patients undergoing DBS: in pre-op, per-op, peri-op and post-op setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with pre operative MRI by intensity	Number of patients with 3 and 7 teslas MRI used before DBS surgery	Day - 21
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.	From enrollment through study completion, an average of 2 years
Number of participants with correct DBS electrodes implantation	The precision of the implantation of the DBS electrodes evaluated by the therapeutic effect obtained in the pathology treated.	Day 0
Number of participants with inter-individual reproducibility of electrophysiological responses	The inter-individual reproducibility of electrophysiological responses with a view to the generalization of this type of approach	From enrollment to the end of study at 18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): April 25, 2036
• Study Completion (Estimated): April 25, 2036

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: MEG; DBS; LFP; IRM; MUA; cognitive tasks
• Other Study ID Numbers: D24-P005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No