Pathology Requiring Deep Brain Stimulation Therapy
Conditions
Keywords
DBS, LFP, MUA, MEG, IRM, cognitive tasks
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.
Interventions
PROCEDUREElectrophysiological 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
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain activity recorded by electrophysiological measurements | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with pre operative MRI by intensity | Day - 21 | Number of patients with 3 and 7 teslas MRI used before DBS surgery |
| Therapeutic effectiveness of DBS | 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 | 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 | 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 |
Countries
France
Contacts
CONTACTPhilippe Domenech, Professor, MD, PhD
Outcome results
None listed