Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Precision Brain Mapping to Predict and Track Response to Exposure and Response Prevention Therapy in Youth With Obsessive-Compulsive Disorder

29. dubna 2026 aktualizováno: Weill Medical College of Cornell University

Precision Functional Mapping to Predict and Track ERP Response in Pediatric Obsessive-Compulsive Disorder: A Longitudinal fMRI Study

The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. ERP is a type of therapy in which participants practice facing OCD-related fears while resisting rituals or compulsions.

The main question this study aims to answer is:

Can each participant's pattern of brain connections, measured with functional MRI brain scans, help predict and track weekly changes in OCD symptoms during and after a 14-week course of ERP, including during planned monthly booster sessions and additional booster sessions offered if symptoms worsen?

All participants will receive ERP. There is no placebo and no comparison group.

Participants will:

  • Complete screening, consent or assent, interviews, questionnaires, and MRI safety checks
  • Receive 14 weekly ERP sessions
  • Complete OCD symptom assessments and functional MRI brain scans before, during, and after ERP
  • Receive planned monthly ERP booster sessions after the 14 weekly sessions
  • Receive additional brief ERP booster sessions if OCD symptoms worsen during follow-up
  • Take part for up to about 62 weeks

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This study examines whether individualized brain-connectivity measures obtained with repeated functional magnetic resonance imaging can help predict and track symptom change during exposure and response prevention, an evidence-based cognitive-behavioral therapy for pediatric obsessive-compulsive disorder.

OCD is characterized by obsessions, compulsions, or both, and in youth it can substantially interfere with school, family life, social development, and daily functioning. Although ERP and serotonin reuptake inhibitor medications are standard treatments for pediatric OCD, clinical outcomes vary. Some youth respond robustly, while others have partial improvement, persistent residual symptoms, or symptom recurrence after initial gains. Current clinical practice lacks individualized biological markers that can track treatment response over time or help identify which patients may require more intensive or alternative intervention strategies.

The scientific rationale for this study is that OCD symptoms have been linked to dysfunction in cortico-striato-thalamo-cortical brain circuits, including orbitofrontal cortex and striatal regions. However, these circuits vary across individuals, and group-average neuroimaging findings have not yet yielded clinically useful biomarkers for individual patients. Precision functional mapping uses repeated fMRI scans from the same person to generate individualized estimates of functional brain networks. By pairing ERP with longitudinal clinical assessment and repeated neuroimaging, this study will evaluate whether participant-specific functional connectivity features, particularly resting-state functional connectivity between orbitofrontal cortex and ventral striatum, are associated with changes in OCD symptom severity over time.

The broader anticipated benefit is scientific: the study may help clarify how individualized brain-connectivity patterns change during ERP and how those changes relate to symptom trajectory, treatment response, and maintenance or recurrence of symptoms. Findings may inform future approaches to personalized pediatric OCD care, including earlier identification of youth who may benefit from treatment augmentation or alternative strategies.

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • New York
      • New York, New York, Spojené státy, 10065
        • NewYork-Presbyterian Hospital / Weill Cornell Medicine
        • Vrchní vyšetřovatel:
          • Conor Liston, MD, PhD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Jihoon Kim, MD, MSc

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 10 to 17 years at the time of initial consent. Participants who reach age 18 while enrolled may remain in the study after completing the adult re-consent process; no new participants age 18 years or older will be recruited.
  • DSM-5 diagnosis of obsessive-compulsive disorder, established through a clinical interview by a clinician.
  • Parent or guardian able to provide informed consent and participant able to provide assent.
  • Participant has sufficient English fluency to complete cognitive tasks and assessments. Parent or guardian English fluency is not required; interpreter support is available.

Exclusion Criteria:

  • History or current evidence of a significant neurological disorder, including but not limited to seizure disorder, stroke, or traumatic brain injury with loss of consciousness.
  • Any standard MRI contraindication identified during initial screening or on the MRI safety checklist, including but not limited to ferromagnetic implants, certain medical devices or metal fragments, severe claustrophobia, or pregnancy.
  • Pregnancy at screening or pregnancy identified during study participation.
  • Active suicidal ideation.
  • Any psychiatric condition that, in the investigator's judgment, would interfere with study participation or data interpretation, including but not limited to psychotic disorders, bipolar disorders, severe neurodevelopmental disorders, intellectual disability, severe eating disorders, or recent significant substance use disorders within the past 6 months. Stable psychiatric comorbidities, including anxiety disorders, depressive disorders, ADHD, or tic disorders, are permitted if OCD remains the primary diagnosis.
  • Any medical, psychiatric, or situational factor judged by the investigator as likely to compromise participant safety, adherence, or data integrity.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Exposure and Response Prevention Therapy
Participants receive exposure and response prevention (ERP) therapy, an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. Participants also receive repeated clinical assessments and research MRI sessions. ERP consists of 14 weekly sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth. Clinical assessments are used to measure OCD symptoms and related outcomes over time, and MRI sessions are used to evaluate brain connectivity.
Behaviorální: Exposure and Response Prevention Therapy
Exposure and response prevention (ERP) is an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. ERP involves graded exposure to obsession-triggering cues while supporting participants in refraining from compulsive responses. In this study, participants receive 14 planned weekly ERP sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth.
Ostatní jména:
  • ERP
  • Prevence expozice a reakce
Jiný: Clinical Assessments
Participants complete repeated clinical assessments according to the study schedule to evaluate obsessive-compulsive disorder symptom severity, symptom change, functioning, safety, and related clinical outcomes over time. Assessments may include clinician-administered ratings, participant-report measures, and other study outcome measures. These assessments are conducted for research and clinical monitoring purposes and are not intended as a therapeutic intervention.
Diagnostický test: Research MRI Sessions
Participants complete research magnetic resonance imaging sessions at scheduled study time points to acquire structural and functional MRI data, including functional MRI measures used to evaluate brain connectivity over time. Imaging sessions are used to examine changes in brain circuitry in relation to obsessive-compulsive disorder symptoms and treatment course. These sessions are conducted for research measurement purposes and are not intended to provide clinical diagnosis or treatment.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP
Časové okno: Baseline through end-of-acute ERP assessment visit, targeted Week 14
The primary outcome is the within-participant association between obsessive-compulsive disorder symptom severity and resting-state functional connectivity during the acute ERP phase. OCD symptom severity will be measured using the Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score. OFC-ventral striatum resting-state functional connectivity will be measured using Fisher z-transformed resting-state fMRI connectivity. The association will be estimated using visit-level linear mixed-effects models. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity.
Baseline through end-of-acute ERP assessment visit, targeted Week 14

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in CY-BOCS-II Total Score at End of Acute ERP
Časové okno: Baseline to end-of-acute ERP assessment visit, targeted Week 14
Clinical symptom change will be measured as the change in Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score from baseline to the end-of-acute ERP assessment visit. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity. A decrease in score indicates improvement.
Baseline to end-of-acute ERP assessment visit, targeted Week 14
Number of Participants With Treatment-Emergent Adverse Events
Časové okno: From first study procedure through last study visit, up to 62 weeks
Safety and tolerability will be assessed by the number and proportion of participants with treatment-emergent adverse events during study participation. Adverse events include unfavorable or unintended signs, symptoms, diseases, or worsening of pre-existing conditions temporally associated with study procedures, whether or not considered related to ERP, MRI/fMRI, symptom-reactivity tasks, or other study procedures.
From first study procedure through last study visit, up to 62 weeks
Change in CY-BOCS-II Total Score From End of Acute ERP to Last Booster or Maintenance Visit
Časové okno: End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
Maintenance of clinical gains will be assessed as the change in Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score from the end-of-acute ERP assessment visit to the last booster or maintenance clinical assessment visit. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity. A decrease in score indicates improvement, while an increase indicates symptom worsening.
End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
Change in OFC-Ventral Striatum Resting-State Functional Connectivity From End of Acute ERP to Last Booster or Maintenance Imaging Visit
Časové okno: End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62
Maintenance of neural change will be assessed as the change in orbitofrontal cortex-ventral striatum resting-state functional connectivity from the end-of-acute ERP imaging visit to the last booster or maintenance imaging visit. Resting-state functional connectivity will be derived from fMRI data and Fisher z-transformed for analysis.
End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Weill Medical College of Cornell University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Conor Liston, MD, PhD, Weill Medical College of Cornell University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

1. září 2030

Dokončení studie (Odhadovaný)

1. srpna 2031

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2026

První zveřejněno (Aktuální)

6. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 25-12029657

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data are not planned to be shared because this study enrolls minors and collects sensitive psychiatric, treatment-context, longitudinal clinical, and MRI/fMRI data. Given the small single-site sample and the potentially identifiable nature of repeated neuroimaging and clinical data, public sharing of participant-level data could create an unacceptable risk of re-identification or unintended disclosure. Aggregate results will be reported. Any future external data sharing would require separate IRB approval, consent/assent authorization or waiver as applicable, institutional data-use agreements, and appropriate de-identification or controlled-access safeguards.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Exposure and Response Prevention Therapy

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Serbia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit