NCT05986578招募中不适用
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
研究概览
简要总结
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-treatment-seeking adults
- •meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- •have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
- •be able to understand the consent form and provide written informed consent
- •be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers
排除标准
- •current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- •in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
- •has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- •Structured Clinical Interview for DSM-5 (SCID-5)
- •Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
- •Assault & Homicidal Danger Assessment Tool - Key to Danger > 1
- •medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
- •history of brain surgery
- •history of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
- •moderate-to-severe heart disease
- •history of stroke
- •is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
- •clozapine137
- •chlorpromazine137
- •clomipramine hydrochloride
- •maprotiline hydrochloride
- •diphenhydramine
- •stimulants other than cocaine including the following:
- •Dextroamphetamine and amphetamine
- •Dextroamphetamine
- •Lisdexamfetamine dimesylate
- •Methamphetamine
- •Methylphenidate
- •having conditions of probation or parole requiring reports of drug use to officers of the court
- •personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
- •serious head injury with loss of consciousness
- •impending incarceration
- •pregnant or nursing for female patients
- •inability to read, write, or speak English
- •for adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
- •hair style that is incompatible with EEG nets
结局指标
主要结局
Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
时间窗: Baseline(before iTBS session),immediately after iTBS session
The Picture Viewing Task will be used to elicit the LPP, reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slide show of images including pleasant, unpleasant, neutral, and cocaine-related images.
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
时间窗: Baseline(before iTBS session),immediately after iTBS session
The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
次要结局
- Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)(Baseline(before iTBS session),immediately after iTBS session)
- Change in pain as assessed by the Visual Analogue Scale(Baseline(before iTBS session),immediately after iTBS session)
- Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)(Baseline(before iTBS session),immediately after iTBS session)
- Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task(Baseline(before iTBS session),immediately after iTBS session)
- Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)(Baseline(before iTBS session),immediately after iTBS session)
研究者
Heather E. Webber, PhD
Instructor
The University of Texas Health Science Center, Houston
研究点 (2)
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