Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Brain activity recorded by electrophysiological measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cognitive tasks performed during electrophysiological recordings
Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS
干预措施: Electrophysiological recordings (Procedure)
结局指标
主要结局
Brain activity recorded by electrophysiological measurements
时间窗: 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
时间窗: 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.
次要结局
- Number of patients with pre operative MRI by intensity(Day - 21)
- Therapeutic effectiveness of DBS(From enrollment through study completion, an average of 2 years)
- Number of participants with correct DBS electrodes implantation(Day 0)
- Number of participants with inter-individual reproducibility of electrophysiological responses(From enrollment to the end of study at 18 months)