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Lo studio clinico NCT06297278 (BRAINS) per Adolescenza è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids (BRAINS)

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06297278 (BRAINS) è uno studio interventistico per Adolescenza, attualmente in arruolamento. Avviato il 17 maggio 2024, prevede di arruolare 174 partecipanti. Sotto la guida di Wayne State University, dovrebbe concludersi entro il 30 aprile 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 7 agosto 2025.
Sommario breve
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.
Titolo ufficiale

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

Condizioni
Adolescenza
Altri ID dello studio
Numero NCT
NCT06297278
Data di inizio (effettiva)
2024-05-17
Ultimo aggiornamento pubblicato
2025-08-07
Data di completamento (stimata)
2028-04-30
Arruolamento (previsto)
174
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
anxiety
exercise
fear
Scopo principale
Ricerca di base
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleModerate Intensity Exercise
Esercizio a intensità moderata
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.
Nessun interventoControl (Coloring)
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Bambino
Età minima
14 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  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 studi clinici attivi da esplorare
National Institute of Mental Health (NIMH) logoNational Institute of Mental Health (NIMH)
Parte responsabile dello studio
Hilary Marusak, Investigatore principale, Assistant Professor, Wayne State University
Nessun dato di contatto
1 Centri dello studio in 1 paesi

Michigan

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