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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-18
• Primary completion: 2036-04-25
• Completion: 2036-04-25
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

2 sites across 1 country: France