Precision Brain Mapping to Predict and Track Response to Exposure and Response Prevention Therapy in Youth With Obsessive-Compulsive Disorder
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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10065
- NewYork-Presbyterian Hospital / Weill Cornell Medicine
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
他の名前：
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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP
時間枠：Baseline through end-of-acute ERP assessment visit, targeted Week 14
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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.
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Baseline through end-of-acute ERP assessment visit, targeted Week 14
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in CY-BOCS-II Total Score at End of Acute ERP
時間枠：Baseline to end-of-acute ERP assessment visit, targeted Week 14
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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.
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Baseline to end-of-acute ERP assessment visit, targeted Week 14
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Number of Participants With Treatment-Emergent Adverse Events
時間枠：From first study procedure through last study visit, up to 62 weeks
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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.
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From first study procedure through last study visit, up to 62 weeks
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Change in CY-BOCS-II Total Score From End of Acute ERP to Last Booster or Maintenance Visit
時間枠：End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
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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.
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End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
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Change in OFC-Ventral Striatum Resting-State Functional Connectivity From End of Acute ERP to Last Booster or Maintenance Imaging Visit
時間枠：End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62
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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.
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End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62
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協力者と研究者
捜査官
- 主任研究者：Conor Liston, MD, PhD、Weill Medical College of Cornell University
出版物と役立つリンク
一般刊行物
- Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
- Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969.
- Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):98-113. doi: 10.1016/j.jaac.2011.09.019.
- Pauls DL, Abramovitch A, Rauch SL, Geller DA. Obsessive-compulsive disorder: an integrative genetic and neurobiological perspective. Nat Rev Neurosci. 2014 Jun;15(6):410-24. doi: 10.1038/nrn3746.
- Gordon EM, Laumann TO, Gilmore AW, Newbold DJ, Greene DJ, Berg JJ, Ortega M, Hoyt-Drazen C, Gratton C, Sun H, Hampton JM, Coalson RS, Nguyen AL, McDermott KB, Shimony JS, Snyder AZ, Schlaggar BL, Petersen SE, Nelson SM, Dosenbach NUF. Precision Functional Mapping of Individual Human Brains. Neuron. 2017 Aug 16;95(4):791-807.e7. doi: 10.1016/j.neuron.2017.07.011. Epub 2017 Jul 27.
- Jaspers-Fayer F, Lin SY, Chan E, Ellwyn R, Lim R, Best J, Belschner L, Lang D, Heran MKM, Woodward TS, Stewart SE. Neural correlates of symptom provocation in pediatric obsessive-compulsive disorder. Neuroimage Clin. 2019;24:102034. doi: 10.1016/j.nicl.2019.102034. Epub 2019 Oct 23.
- Lynch CJ, Elbau IG, Ng T, Ayaz A, Zhu S, Wolk D, Manfredi N, Johnson M, Chang M, Chou J, Summerville I, Ho C, Lueckel M, Bukhari H, Buchanan D, Victoria LW, Solomonov N, Goldwaser E, Moia S, Caballero-Gaudes C, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM, Kay K, Aloysi A, Gordon EM, Bhati MT, Williams N, Power JD, Zebley B, Grosenick L, Gunning FM, Liston C. Frontostriatal salience network expansion in individuals in depression. Nature. 2024 Sep;633(8030):624-633. doi: 10.1038/s41586-024-07805-2. Epub 2024 Sep 4.
- McGuire JF, Piacentini J, Lewin AB, Brennan EA, Murphy TK, Storch EA. A META-ANALYSIS OF COGNITIVE BEHAVIOR THERAPY AND MEDICATION FOR CHILD OBSESSIVE-COMPULSIVE DISORDER: MODERATORS OF TREATMENT EFFICACY, RESPONSE, AND REMISSION. Depress Anxiety. 2015 Aug;32(8):580-93. doi: 10.1002/da.22389. Epub 2015 Jun 30.
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- 25-12029657
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