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Clinical Trial NCT06297278 (BRAINS) for Adolescence is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids (BRAINS)

Recruiting
Clinical Trial NCT06297278 (BRAINS) is an interventional study for Adolescence that is recruiting. It started on 17 May 2024 with plans to enroll 174 participants. Led by Wayne State University, it is expected to complete by 30 April 2028. The latest data from ClinicalTrials.gov was last updated on 7 August 2025.
Brief Summary
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.
Official Title

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

Conditions
Adolescence
Other Study IDs
NCT ID Number
NCT06297278
Start Date (Actual)
2024-05-17
Last Update Posted
2025-08-07
Completion Date (Estimated)
2028-04-30
Enrollment (Estimated)
174
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
anxiety
exercise
fear
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalModerate Intensity Exercise
Moderate Intensity Exercise
Participants randomized to the active (moderate intensity) exercise condition will complete a 3-minute warm-up at low speed on a treadmill. Speed and incline will be increased in 3-minute increments until moderate-intensity exercise, defined as participants staying within a zone of 60-80% AAMHR with the target being to attain and maintain 70-75% AAMHR while briskly walking and/or jogging depending on current fitness status, is reached for a total of 30 min.
No InterventionControl (Coloring)
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Skin Conductance Responding (SCR)
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.).
Throughout study completion (3 days)
Unconditioned Stimulus (US) Expectancy Ratings
US Expectancy Ratings will be measured during fear learning, extinction, and recall tasks
Throughout study completion (3 days)
Fear extinction neural circuitry: Functional activation and coupling
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).
Neuroimaging will occur during the fear extinction recall phase on Day 3
Endocannabinoid (eCB) Concentrations
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.
eCB concentrations will be measured in plasma and saliva immediately before and after the exercise or control condition on Day 2
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Fear Ratings
Fear ratings to each CS will be captured at the beginning, middle, and end of each phase, using a response pad and a 1-5 visual analog scale (1 = not scary at all, 5 = very scary).
Throughout study completion (3 days)
Approach/Avoidance Behavior
The investigators will quantify forward-to-backward response pad distance in virtual meters from the conditioned stimulus.
Throughout study completion (3 days)
Amygdala response during extinction recall
MRI Eligible Only: fMRI blood-oxygen-level-dependent (BOLD) response will be measured across the entire brain during a test of extinction recall. A secondary region of interest is amygdala response during recall (CS+E\>CS+U).
Neuroimaging will occur during the fear extinction recall phase on Day 3
Eligibility Criteria

Eligible Ages
Child
Minimum Age
14 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and available for the duration of the study
  3. 14-17 years of age upon enrollment
  4. Right-handed
  5. In good general health as evidenced by medical history
  6. Adolescent and parent/guardian are English-speaking, as study assessments are in English
  7. Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

  1. Traumatic brain injury with ongoing symptoms
  2. Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
  3. MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
  4. Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
  5. Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
  6. Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
  7. 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
  8. Currently pregnant, lactating, or positive pregnancy test at screening visit
  9. Current homicidal thoughts or suicide attempt in the past year
  10. Current suicidal thoughts requiring immediate intervention
  11. Concurrent use (past 6 weeks) of oral contraceptives
  12. Diagnosed or probable substance use disorder (past 1-month)
  13. Positive drug test at baseline visit (e.g., THC, cocaine)
  14. Moderate/severe drug or alcohol use in the past 8 weeks
  15. Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
  16. Treatment with investigational drug or intervention (past 1-month)
  17. Current smoker, vaper, or tobacco or nicotine use (past 1-month)
  18. Ongoing exposure to abuse
Wayne State University logoWayne State University60 active trials to explore
National Institute of Mental Health (NIMH) logoNational Institute of Mental Health (NIMH)
Study Responsible Party
Hilary Marusak, Principal Investigator, Assistant Professor, Wayne State University
No contact data.
1 Study Locations in 1 Countries

Michigan

Tolan Park Medical Building, Detroit, Michigan, 48201, United States
MacKenna Shampine, Contact, 313-242-7464‬, [email protected]
Recruiting