Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Sondaggio sui biomarcatori OCD che utilizza sEEG e stimolazione: lo studio OBSESS

30 settembre 2026 aggiornato da: Sameer Sheth, Baylor College of Medicine

Traditional strategies for diagnosing psychiatric disorders focus on definitions based on constellations of co-occurring symptoms. Tracking symptom severity across therapy arcs relies on administering scales that again ask questions about symptoms. These strategies have allowed some degree of standardization but suffer from having a phenomenological rather than mechanistic foundation (in terms of diagnosis) as well as subjectivity and temporal sparseness (in terms of measurement).

The investigators apply a transdiagnostic framework based on the neurobiological concept of approach behavior. Several psychiatric disorders (including OCD, uni- and bipolar depression, PTSD and anxiety disorders, and addiction disorders) are characterized by dysfunction in approach behavior. The investigators study the neurobehavioral basis of approach dysfunction in a cohort of individuals with severe OCD and bipolar disorder (BD). To study these behaviors, the investigators deploy a suite of wearables and peripherals (Oura ring, Apple Watch, iPhone, audioband) that allow continuous and dense measurement of behaviors relevant to the approach hypothesis: socialization, activity, and sleep patterns. The investigators perform these measurements in two selected environments. One is a novel apartment-style setting (neurobehavioral unit, NBU) that combines the high-bandwidth data acquisition capability of a lab with the naturalistic relevance and comfort of the home. The second is the truly natural and maximally ethologically relevant setting of the ambulatory "home" environment in which people spend the majority of their time.

The participants will be individuals planned for deep brain stimulation (DBS) implant for their OCD or BD. The bi-directional (stimulate as well as record) nature of the DBS systems will allow neural recordings that the investigators will synchronize with the behavioral data streams. The investigators will apply predictive computational models in conjunction with the causal manipulation provided by stimulation to test mechanistic hypothesis relating neurophysiology, behavior, and clinical status. In Aim 1, The investigators study reward-driven decision making by employing an augmented reality approach-avoidance task in the NBU. In Aim 2, the investigators test the neurobehavioral models' ability to predict clinical status from passively (and therefore low burden to patient-participants) acquired data in the "home" environment. In Aim 3, the investigators identify neural predictors of the patterns of sleep dysregulation associated with these disorders using the unique environment of the NBU. In Aim 4, the investigators examine critical concepts of ethics and ethology that arise with this new field of naturalistic, chronic brain-behavior relationship investigation.

The investigators hope that methods validated and lessons learned in this project will improve understanding of the mechanistic basis of a range of psychiatric disorders and thereby allow greater rational design of therapeutic delivery.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Traditional strategies for diagnosing psychiatric disorders focus on definitions based on constellations of co-occurring symptoms. Tracking symptom severity across therapy arcs relies on administering scales that again ask questions about symptoms. These strategies have allowed some degree of standardization but suffer from having a phenomenological rather than mechanistic foundation (in terms of diagnosis) as well as subjectivity and temporal sparseness (in terms of measurement).

The investigators apply a transdiagnostic framework based on the neurobiological concept of approach behavior. Several psychiatric disorders (including OCD, uni- and bipolar depression, PTSD and anxiety disorders, and addiction disorders) are characterized by dysfunction in approach behavior. The investigators study the neurobehavioral basis of approach dysfunction in a cohort of individuals with severe OCD and bipolar disorder (BD). To study these behaviors, the investigators deploy a suite of wearables and peripherals (Oura ring, Apple Watch, iPhone, audioband) that allow continuous and dense measurement of behaviors relevant to the approach hypothesis: socialization, activity, and sleep patterns. The investigators perform these measurements in two selected environments. One is a novel apartment-style setting (neurobehavioral unit, NBU) that combines the high-bandwidth data acquisition capability of a lab with the naturalistic relevance and comfort of the home. The second is the truly natural and maximally ethologically relevant setting of the ambulatory "home" environment in which people spend the majority of their time.

The participants will be individuals planned for deep brain stimulation (DBS) implant for their OCD or BD. The bi-directional (stimulate as well as record) nature of the DBS systems will allow neural recordings that the investigators will synchronize with the behavioral data streams. The investigators will apply predictive computational models in conjunction with the causal manipulation provided by stimulation to test mechanistic hypothesis relating neurophysiology, behavior, and clinical status. In Aim 1, The investigators study reward-driven decision making by employing an augmented reality approach-avoidance task in the NBU. In Aim 2, the investigators test the neurobehavioral models' ability to predict clinical status from passively (and therefore low burden to patient-participants) acquired data in the "home" environment. In Aim 3, the investigators identify neural predictors of the patterns of sleep dysregulation associated with these disorders using the unique environment of the NBU. In Aim 4, the investigators examine critical concepts of ethics and ethology that arise with this new field of naturalistic, chronic brain-behavior relationship investigation.

The investigators hope that methods validated and lessons learned in this project will improve understanding of the mechanistic basis of a range of psychiatric disorders and thereby allow greater rational design of therapeutic delivery.

Tipo di studio

Interventistico

Iscrizione (Stimato)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02912
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Planned for DBS for OCD (via clinical pathway, FDA HDE, IRB) or BD (via BRAIN-funded UH3 trial)
  • Agrees to study activities in NBU and "home" environments

Exclusion Criteria:

- Planned to receive non-rechargeable DBS generator

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Neurostimolatore Medtronic Percept RC

Medtronic SenSight directional DBS leads and implanted pulse generators (IPGs) will be implanted

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
Lasso di tempo: Through study completion, an average of 14 months

Severity of depression symptoms. Changes in the Yale-Brown Obsessive Compulsive Scale survey/questionnaire. YBOCS is an assessment to rate symptoms of OCD on a scale of 0-50 (with a higher number indicating a more severe outcome ratings of OCD and 0 indicated no symptoms of OCD).

Through study completion, an average of 14 months
Change in Hamilton Depression Inventory (HAM-D) Score
Lasso di tempo: Through study completion, an average of 14 months

Severity of depression symptoms. Changes in the Hamilton Depression Inventory (HAM-D) score. HAM-D is an assessment to rate symptoms of depression on a scale of 0-52 (with a higher number indicating a more severe outcome ratings of depression and 0 indicated no symptoms of depression).

Through study completion, an average of 14 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2027

Completamento primario (Stimato)

1 agosto 2029

Completamento dello studio (Stimato)

1 agosto 2029

Date di iscrizione allo studio

Primo inviato

27 maggio 2022

Primo inviato che soddisfa i criteri di controllo qualità

14 giugno 2022

Primo Inserito (Effettivo)

16 giugno 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 56119

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .