Идёт набор 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

Без фазы С лечением Pathology Requiring Deep Brain Stimulation Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Electrophysiological recordings.
Кому может быть актуально: Состояния в реестре: Pathology Requiring Deep Brain Stimulation Therapy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Процедура 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

Первичные конечные точки

Brain activity recorded by electrophysiological measurements [Срок оценки: From enrollment through study completion, an average of 2 years]
Therapeutic effectiveness of DBS [Срок оценки: From enrollment through study completion, , an average of 2 years]

Вторичные конечные точки (4)

Number of patients with pre operative MRI by intensity [Срок оценки: Day - 21]
Therapeutic effectiveness of DBS [Срок оценки: From enrollment through study completion, an average of 2 years]
Number of participants with correct DBS electrodes implantation [Срок оценки: Day 0]
Number of participants with inter-individual reproducibility of electrophysiological responses [Срок оценки: From enrollment to the end of study at 18 months]

Критерии участия

Критерии включения

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