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Adaptive DBS in Non-Motor Neuropsychiatric Disorders: Regulating Limbic Circuit Imbalance

非运动神经精神疾病的适应性 DBS：调节边缘回路不平衡

基本信息

批准号：
10451827
负责人：
Wayne K Goodman
金额：
$ 154.43万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-30 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10451827
关键词：
Acute Adult Affect Affective Algorithms Anatomy Anxiety Architecture Behavior Behavioral Bilateral Biological Markers Blinded Brain Classification Clinic Clinical Cognitive Therapy Computers Data Deep Brain Stimulation Devices Distress Electric Stimulation Electrodes Electroencephalography Emotional Exposure to Face Failure Feasibility Studies Feedback Functional Magnetic Resonance Imaging Funding Generations Home Human Implant Investigation Label Measures Mental disorders Meta-Analysis Moods Negative Valence Neurosurgical Procedures Obsessive-Compulsive Disorder Operative Surgical Procedures Outcome Pacemakers Patient Selection Patient Self-Report Patients Pattern Phase Physiologic pulse Physiological Policies Positive Valence Procedures Regulation Research Resistance Rest Risk Safety Scalp structure Scanning Severities Signal Transduction Site Stream Symptoms System Technology Telemetry Testing Therapeutic Time Training Ventral Striatum Width algorithm training base biosignature design feasibility testing hypomania implantation individual patient meetings neural circuit neuropsychiatric disorder neurosurgery open label phase change prototype reduce symptoms response side effect symptom management symptomatic improvement tool tractography

项目摘要

In patients with intractable Obsessive-Compulsive Disorder (OCD), ventral striatum (VS) deep brain stimulation (DBS) effectively reduces symptom severity in about 60% of cases. However, there is room for improvement in both clinical benefits and reduction of DBS-induced behavioral side effects, especially hypomania. A critical factor may be failure to adaptively adjust DBS in response to phasic changes in negatively and positively valenced states (i.e., OCD-related distress and hypomania, respectively). New generation adaptive DBS (aDBS) systems can record, stimulate and use signals from the brain to make responsive adjustments to the patient's behavioral state. Specific Aim 1 is to train the device to accurately classify acute fluctuations in OCD- related distress and emergence of hypomania and distinguish these states from other affective states that do not require adjustments in stimulation. Specific Aim 2 is to develop adaptive control policies that can automatically adjust stimulation parameters to regulate these undesired states. It is hypothesized that exacerbations in OCD-related distress will require increased stimulation (higher amplitude or wider pulse width) whereas hypomania will respond to decreased stimulation. These aims will be executed using a two-phase Early Feasibility Study of aDBS in 10 adults with intractable OCD. Subjects will enter a 6-month trial of open- label bilateral aDBS followed by 2 months of adjunctive cognitive behavioral therapy (CBT). Subsequently, they will enter a 4-week blinded discontinuation period to assess need for ongoing DBS. In Phase I, 5 subjects will have surgery as per procedures of the FDA Human Device Exemption (HDE) approval for VS DBS in OCD. Electrode implantation will be optimized and personalized using “precision mapping” of each patient's anatomical connectivity from high-field tractography in native space. DBS programming sessions will also serve to train the algorithms to classify different valence states. For example, a symptom provocation paradigm will elicit different levels of manageable OCD-related distress. During this paradigm multiple streams of time- locked physiological and behavioral data will be captured to build a classifier: Local Field Potentials (LFPs) from the VS, Scalp EEG, and Automated Facial Affect Recognition (AFAR), which objectively measures emotional valence. We hypothesize that classifiers using combined LFP/EEG data will perform better than VS LFPs alone, but that direct cortical recordings will be needed for accurate classification and creation of a fully embedded, self-contained, aDBS system. In Phase II, 5 subjects will have VS DBS surgery along with bilateral subdural placement of electrocorticographic (ECoG) recording leads at a prefrontal target, informed by resting state functional MRI from Phase I and pre-operative scans. New classifiers will be built based on VS and ECoG LFPs and adaptive stimulation algorithms tested in the clinic before transfer to the ambulatory setting. Meeting all study milestones would result in a prototype ambulatory aDBS system that would manage fluctuations in OCD symptoms and device-related side effects automatically.

顽固性强迫症（OCD）患者，腹侧纹状体（VS）深部脑刺激

项目成果

期刊论文数量（13）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Continued access to investigational brain implants.

DOI：
10.1038/s41583-018-0004-5
发表时间：
2018-06
期刊：
Nature reviews. Neuroscience
影响因子：
0
作者：
Lázaro-Muñoz G;Yoshor D;Beauchamp MS;Goodman WK;McGuire AL
通讯作者：
McGuire AL

Automated Detection of Enhanced DBS Device Settings.

DOI：
10.1145/3395035.3425354
发表时间：
2020-10
期刊：
Companion Publication of the 2020 International Conference on Multimodal Interaction
影响因子：
0
作者：
Ding Y;Ertugrul IO;Darzi A;Provenza N;Jeni LA;Borton D;Goodman W;Cohn J
通讯作者：
Cohn J

Decoding task engagement from distributed network electrophysiology in humans.

从人类分布式网络电生理学中解码任务参与度。

DOI：
10.1088/1741-2552/ab2c58
发表时间：
2019
期刊：
Journal of neural engineering
影响因子：
4
作者：
Provenza,NicoleR;Paulk,AngeliqueC;Peled,Noam;Restrepo,MariaI;Cash,SydneyS;Dougherty,DarinD;Eskandar,EmadN;Borton,DavidA;Widge,AlikS
通讯作者：
Widge,AlikS

Treatment Search Fatigue and Informed Consent.