An interventional study of Electrophysiological recordings in Pathology Requiring Deep Brain Stimulation Therapy, sponsored by Centre Hospitalier St Anne. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Basic science
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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.
Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS
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
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)
Time frame: 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.
Time frame: From enrollment through study completion, , an average of 2 years
Number of patients with pre operative MRI by intensity
Number of patients with 3 and 7 teslas MRI used before DBS surgery
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of study at 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Apr 2036, 139 months after the start.
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