跳至主要内容
临床试验/NCT06297278
NCT06297278招募中不适用

Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids

Wayne State University2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2024年5月17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
174
试验地点
2
主要终点
Fear extinction neural circuitry: Functional activation and coupling

研究概览

简要总结

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

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
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and available for the duration of the study
  • 14-17 years of age upon enrollment
  • Right-handed
  • In good general health as evidenced by medical history
  • Adolescent and parent/guardian are English-speaking, as study assessments are in English
  • Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

排除标准

  • Traumatic brain injury with ongoing symptoms
  • Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
  • MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
  • Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
  • Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
  • Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
  • Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study
  • Currently pregnant, lactating, or positive pregnancy test at screening visit
  • Current homicidal thoughts or suicide attempt in the past year
  • Current suicidal thoughts requiring immediate intervention
  • Concurrent use (past 6 weeks) of oral contraceptives
  • Diagnosed or probable substance use disorder (past 1-month)
  • Positive drug test at baseline visit (e.g., THC, cocaine)
  • Moderate/severe drug or alcohol use in the past 8 weeks
  • Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
  • Treatment with investigational drug or intervention (past 1-month)
  • Current smoker, vaper, or tobacco or nicotine use (past 1-month)
  • Ongoing exposure to abuse

结局指标

主要结局

Fear extinction neural circuitry: Functional activation and coupling

时间窗: Neuroimaging will occur during the fear extinction recall phase on Day 3

MRI eligible only: fMRI blood-oxygen-level-dependent (BOLD) response will be measured across the entire brain during a test of extinction recall. The investigators will focus on response in the hippocampus and ventromedial prefrontal cortex activation and coupling (gPPI) during recall (CS+E\>CS+U).

Skin Conductance Responding (SCR)

时间窗: Throughout study completion (3 days)

To compare the effects of acute moderate-intensity exercise (vs. sedentary control) on extinction recall, the investigators will place three electrodes on participant's left hand to acquire SCR data using a BIOPAC MP160 Data Acquisition System (BIOPAC Systems, Inc.).

Unconditioned Stimulus (US) Expectancy Ratings

时间窗: Throughout study completion (3 days)

US Expectancy Ratings will be measured during fear learning, extinction, and recall tasks

Endocannabinoid (eCB) Concentrations

时间窗: eCB concentrations will be measured in plasma and saliva immediately before and after the exercise or control condition on Day 2

Plasma and saliva samples will be collected immediately before and after exercise or sedentary control condition. Samples will be analyzed using liquid chromatography-mass spectrometry to quantify concentrations of eCBs.

次要结局

  • Fear Ratings(Throughout study completion (3 days))
  • Approach/Avoidance Behavior(Throughout study completion (3 days))
  • Amygdala response during extinction recall(Neuroimaging will occur during the fear extinction recall phase on Day 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilary Marusak

Assistant Professor

Wayne State University

研究点 (2)

Loading locations...

相似试验