Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable Obsessive-Compulsive Disorder (OCD) Phase II Using Summit RC+S System With ECoG Paddles
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Percent of subjects that display biomarkers of OCD-related distress
研究概览
简要总结
This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD affects 2-3% of the US population, and is responsible for substantial functional impairment and increased risk of early death.
The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure and response prevention and certain medications. About 30-40% of patients fail to respond and few experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT and the risk of relapse after therapies remains large. For the most severe cases, neurosurgery (surgery in the brain), has long been the option of last resort.
In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep brain stimulation (DBS) remains investigational for OCD patients and is not considered standard therapy. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for OCD treatment.
This current research protocol will focus on the completion of Phase II which will implant the RC+S system with ECoG paddles in 5 subjects.
详细描述
ENROLLMENT: A subject is considered enrolled upon signing informed consent and deemed eligible to be screened by the investigator. The informed consent process may include discussions with the patients family and referring clinician. Medical records that can be obtained will be carefully reviewed to determine adequacy of past treatments including Cognitive Behavioral Therapy (CBT).
A subject identification number will be assigned to each subject that signs consent. This number will be used to identify the subject and must be used on all study documentation related to that subject throughout the study.
SCREENING: Potential subjects meeting inclusion/exclusion criteria and willing to participate in the study as demonstrated by signing the informed consent will be enrolled in the study and undergo 2 screening visits (Visit 1 and Visit 2) spaced over an approximate 1 month period. Diagnostic and screening ratings are completed, followed by complete medical, neurological and neurosurgical evaluations. Final selection of candidates will be made by consensus of the multi-disciplinary investigator team (Project Advisory Committee).
Neuroimaging Methods:
The Core for Advanced MR Imaging (CAMRI) is a state-of-the-art resource housing 3 cutting edge MRI systems for the Houston research community, located at BCM Main Campus. CAMRI will perform the research 3T MRI scans, which will be collected on all subjects (DBS and control) using the Prisma scanner for consistency. All subjects will be escorted to CAMRI by the study team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study specific procedures being performed
- •Male or female between ages 21 and 70;
- •At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- •A primary diagnosis of OCD with Y-BOCS minimum score of 28;
- •Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
- •Failed or could not tolerate an adequate trial of clomipramine;
- •Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
- •Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- •Stable psychotropic medical regimen for the month preceding surgery
排除标准
- •Inability or refusal to give informed consent.
- •Lifetime diagnosis of psychotic disorders such as schizophrenia;
- •Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- •Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
- •Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
- •Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
- •Need for Diathermy
- •Contraindications to MRI
- •Contraindications to MEG
- •Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.
研究组 & 干预措施
One Month Blinded Discontinuation Period
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline
干预措施: One Month Blinded Discontinuation Period: (Other)
Summit RC+S DBS Implant for OCD
All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles
干预措施: Summit RC+S System with ECoG Paddles (Device)
结局指标
主要结局
Percent of subjects that display biomarkers of OCD-related distress
时间窗: Month 18
electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.
Percent of subjects that display biomarkers of DBS-induced hypomania
时间窗: Month 18
electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.
次要结局
- Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity(Baseline to 30 days)
研究者
Wayne Goodman MD
D. C. and Irene Ellwood Professor and Chair
Baylor College of Medicine