Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Duration of compulsive behaviors in response to laboratory triggers
研究概览
简要总结
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will:
- •Be between the ages of 18 and 60 years
- •Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
- •Agree to video taping of structured clinical interview
- •Report that they will reside in the Pittsburgh area for at least 5 weeks
排除标准
- •Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
- •Medical contraindications for Transcranial Magnetic Stimulation (TMS):
- •Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
- •Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
- •Metallic implants in body or other devices that may be affected by magnetic field
- •Significant heart disease or cerebrovascular disease
- •Medications with strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)
- •Acute suicidality or other psychiatric crises requiring treatment escalation
- •Changes made to treatment regimen within 4 weeks of baseline assessment
- •Reading level <6th grade as per participant self-report
- •Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, opiates, amphetamines, and barbiturates)
- •Presence of movement disorder or tics affecting manual responses
- •Inability to read text from 2 feet away (corrective lenses allowed)
研究组 & 干预措施
cTBS + Sham Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
干预措施: Transcranial Magnetic Stimulation (Device)
cTBS + Habit Override Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
干预措施: Habit Override Practice (Behavioral)
cTBS + Habit Override Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.
干预措施: Transcranial Magnetic Stimulation (Device)
Sham TBS + Habit Override Training
Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
干预措施: Habit Override Practice (Behavioral)
Sham TBS + Habit Override Training
Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
cTBS + Sham Training
Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.
干预措施: Sham Training (Behavioral)
Sham TBS + Sham Training
Sham Transcranial Magnetic Stimulation, paired with Sham Training.
干预措施: Sham Training (Behavioral)
Sham TBS + Sham Training
Sham Transcranial Magnetic Stimulation, paired with Sham Training.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Duration of compulsive behaviors in response to laboratory triggers
时间窗: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
时间窗: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
Brain activation in target region
时间窗: 10-60min post-intervention
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Effort to resist compulsive behaviors in response to laboratory triggers
时间窗: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
次要结局
- Goal-directed cognition(90min-1 week)
- Obsessive Compulsive Inventory-Revised (OCI-R)(1 week)
- Intensity of urges to perform compulsive behaviors in response to laboratory triggers(1 week)
- Brain activation in target region(1 week)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(1 week)
- Effort to resist compulsive behaviors in response to laboratory triggers(1 week)
- WHO Disability Assessment Scale 2.0(1 week)
- Duration of compulsive behaviors in response to laboratory triggers(1 week)
研究者
Rebecca Price
Associate Professor of Psychiatry
University of Pittsburgh