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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive tasks performed during electrophysiological recordings | Experimental | Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Domenech, Professor, MD, PhD | Contact | 0033(0)149812201 | philippe.domenech@ghu-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble-Alpes Hospital Center | Not yet recruiting | Grenoble | 38043 | France |
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| 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 |
| Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris | Recruiting | Paris | 75014 | France |
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