Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable OCD: Phase Ib Using Summit RC+S
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 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/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 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 deep brain stimulation 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 Ib which will implant the RC+S system in 2 subjects.
详细描述
ENROLLMENT: A subject is considered enrolled upon signing informed consent, deemed eligible to be screened by the investigator. The informed consent process may include discussions with the patient¿s 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:
DBS implanted subjects will undergo 2- 3T MRI Scans prior to surgery (1 research MRI at CAMRI and 1 clinical MRI at BSLMC). DBS implanted subjects will under 3 MEGs total.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OCD DBS Subject Inclusion criteria:
- •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;
- •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 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
- •Non-Implanted Control Subject Inclusion criteria:
- •Signed informed consent prior to any study specific procedures being performed
- •Male or female between ages 21 and 70
排除标准
- •OCD DBS Subject Exclusion criteria:
- •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
- •Non-Implanted Control Subject Exclusion criteria:
- •Inability or refusal to give informed consent.
- •Lifetime diagnosis of mental illness
- •A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
- •Any neurological disorders (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
- •Pregnant (confirmed by self-report for females of child bearing age)
- •Contraindications to MRI
研究组 & 干预措施
Summit RC+S DBS Implant for OCD
all subjects will receive surgical implantation of DBS system
干预措施: Summit RC+S System (Device)
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)
结局指标
主要结局
Percent of subjects that display biomarkers of OCD-related distress
时间窗: [Time Frame: Month 18]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) 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: [Time Frame: Month 18]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.
Percent of subjects that display biomarkers of OCD-related distress
时间窗: [Time Frame: Month 6]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) 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 OCD-related distress
时间窗: [Time Frame: Month 9]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) 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 OCD-related distress
时间窗: Time Frame: Month 12]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) 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: [Time Frame: Month 6]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.
Percent of subjects that display biomarkers of DBS-induced hypomania
时间窗: [Time Frame: Month 9]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) from the brain showing Cohen's kappa k \> 0.40, chance corrected classification agreement with DBS therapy during clinical visits.
Percent of subjects that display biomarkers of DBS-induced hypomania
时间窗: [Time Frame: Month 12]
electrophysiological signals (deep brain local field potentials with scalp electroencephalography) 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([Time Frame: Baseline to 30 days])
研究者
Wayne Goodman MD
D. C. and Irene Ellwood Professor and Chair
Baylor College of Medicine