Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrophysiological recordings.
- Who it may be relevant to
- Registry conditions: Pathology Requiring Deep Brain Stimulation Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Brain activity recorded by electrophysiological measurements [Time frame: From enrollment through study completion, an average of 2 years]
- Therapeutic effectiveness of DBS [Time frame: From enrollment through study completion, , an average of 2 years]
Secondary outcome measures (4)
- Number of patients with pre operative MRI by intensity [Time frame: Day - 21]
- Therapeutic effectiveness of DBS [Time frame: From enrollment through study completion, an average of 2 years]
- Number of participants with correct DBS electrodes implantation [Time frame: Day 0]
- Number of participants with inter-individual reproducibility of electrophysiological responses [Time frame: From enrollment to the end of study at 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 2 centers
- Grenoble-Alpes Hospital Center — Grenoble
- Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris — Paris
Identifiers
NCT: NCT06813300 · D24-P005