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NCT Number: 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

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.

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Key information

Conditions

Pathology Requiring Deep Brain Stimulation Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble-Alpes Hospital Center, Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Brain activity recorded by electrophysiological measurements

Time frame: From enrollment through study completion, an average of 2 years

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

Time frame: From enrollment through study completion, , an average of 2 years

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.

Secondary outcomes

Number of patients with pre operative MRI by intensity

Time frame: Day - 21

Number of patients with 3 and 7 teslas MRI used before DBS surgery
Therapeutic effectiveness of DBS

Time frame: From enrollment through study completion, an average of 2 years

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.
Number of participants with correct DBS electrodes implantation

Time frame: Day 0

The precision of the implantation of the DBS electrodes evaluated by the therapeutic effect obtained in the pathology treated.
Number of participants with inter-individual reproducibility of electrophysiological responses

Time frame: From enrollment to the end of study at 18 months

The inter-individual reproducibility of electrophysiological responses with a view to the generalization of this type of approach

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Domenech, Professor, MD, PhD

CONTACT

[email protected]

0033(0)149812201

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Acronym: LFP-DBS 2024

Important dates

Study start: 2024
Primary completion: 2036
Study completion: 2036
First posted: Feb 6, 2025
Registry last updated: Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.