TMS + Exposure Therapy for Pediatric OCD: Second Phase (NExT)
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
The goal of this clinical trial is to test transcranial magnetic stimulation (TMS) for improving the outcomes of Exposure with Response Prevention (ERP) in youth and young adults with Obsessive-Compulsive Disorder (OCD). Researchers will compare two groups: ERP with active ("real") TMS vs. ERP with sham ("fake") TMS. The first phase of this study found that active TMS+ERP normalized functioning in brain circuits that contribute to compulsive behavior. This second phase will test whether TMS-induced brain changes lead to improvements in OCD symptom severity. Participants will:
- Complete clinical interviews, questionnaires, and computerized tasks
- Complete two MRIs (brain scans)
- Receive daily TMS followed by ERP for two weeks (10 sessions)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Pediatric OCD is a public health problem and many remain symptomatic even after receiving efficacious treatments. The success of exposure and response prevention (ERP), a first-line behavioral treatment, depends on the ability to refrain from compulsions during exposure tasks. Improving this "therapy critical behavior" is a potentially important strategy for ERP augmentation. Repetitive transcranial magnetic stimulation (rTMS) can be leveraged to stimulate healthier functioning of brain circuits underlying therapy critical behaviors. The overall objective of this project is to test whether augmenting ERP with rTMS over cortical nodes of select cortico-striatal circuits implicated in compulsivity can normalize connectivity and enhance response prevention in youth and young adults with OCD. This project will use a masked RCT design to test whether ERP+TMS engages hypothesized circuits involved in compulsivity and whether this leads to clinical improvement. Youth ages 12-21 years with OCD will complete a full course of ERP plus randomly assigned TMS regimens of sham or continuous theta burst stimulation (cTBS) to the presupplementary motor area (pSMA; n=30 per group).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kristen Benito, PhD
- Numéro de téléphone: 4014321054
- E-mail: kbenito@brownhealth.org
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55414
- Recrutement
- University of Minnesota
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Contact:
- Christine Conelea, PhD
- Numéro de téléphone: 612-261-3127
- E-mail: cconelea@umn.edu
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Rhode Island
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Providence, Rhode Island, États-Unis, 02915
- Recrutement
- Emma Pendleton Bradley Hospital
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Contact:
- Kristen Benito, PhD
- Numéro de téléphone: 4014321054
- E-mail: kbenito@brownhealth.org
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Between the ages of 12 and 21 years.
- Presence of OCD, as indicated by a score of > 16 on the Children's Yale-Brown Obsessive Compulsive Scale, indicating moderate or greater OCD symptoms.
- Presence of motor compulsions on CY-BOCS compulsion checklist
- English fluency to ensure comprehension of informed consent and study measures and instructions.
Exclusion Criteria:
- Decline to provide informed consent.
- Has a personal history, or a family history in a first-born relative, of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) impact the risk profile of TMS; (2) reduce the subject's ability to fulfill the study requirements as per protocol; or (3) adversely impact the integrity of the data or the validity of the study results." Some examples include: epilepsy or seizure disorder(s), bipolar disorder or any psychiatric disorder associated with a risk of mania, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
- Pregnant according to the medical history or a urine pregnancy test; and menstruating females who are heterosexually active and not using a highly effective form of contraception (tubal ligation, FDA-approved hormonal contraceptive, or an IUD)
- Inability to undergo MRI.
- Is deemed to be at imminent risk of suicide according to the Ask Suicide-Screening Questions (ASQ) (i.e. answers YES to ≥ one (1) of the four screening questions) and/or in the medical opinion of the investigator
- History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture).
- Concurrent psychotherapy of any kind for OCD.
- Concurrent TMS or receipt of any TMS experimental or clinical treatment less than 3 months prior to enrollment.
- Taking a medication deemed to pose high seizurogenic potential per physician review
- Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the study period)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ERP+cTBS
Participants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP). |
TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern
Autres noms:
ERP will be delivered daily, immediately following TMS
Autres noms:
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Comparateur actif: ERP+Sham
Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP). |
ERP will be delivered daily, immediately following TMS
Autres noms:
Sham stimulation will use the Magstim sham air-cooled coil, which produces auditory signals and appears identical to an active coil but contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (<3%) magnetic field is delivered to the cortex
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
Délai: two weeks (post-treatment)
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correlation coefficient representing resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS) |
two weeks (post-treatment)
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Observed Compulsive Behavior
Délai: two weeks
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Duration of time during which compulsions are observed during ERP sessions |
two weeks
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Child/Adult Yale-Brown Obsessive Compulsive Inventory
Délai: six weeks (1-month follow-up)
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Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale |
six weeks (1-month follow-up)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Global Impressions Scale-Improvement
Délai: six weeks (1-month follow-up)
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Independent-Evaluator (IE) rated measure of clinical improvement. Rated on 1 (very much improved) to 7 (very much worse) scale |
six weeks (1-month follow-up)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kristen Benito, PhD, Emma Pendleton Bradley Hospital
- Chercheur principal: Christine Conelea, University of Minnesota
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Comportement impulsif
- Comportement
- Comportement compulsif
- Thérapeutique
- Modalités de physiothérapie
- Thérapie comportementale
- Psychothérapie
- Disciplines et activités comportementales
- Réhabilitation
- Anesthésie et analgésie
- Thérapie de stimulation électrique
- Analgésie
- Désensibilisation, psychologique
- Thérapie cognitivo-comportementale
- Stimulation du nerf électrique transcutané
- Thérapie implosive
Autres numéros d'identification d'étude
- 2113426
- R33MH133666 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
We will share all de-identified data from study measures through the National Institute of Mental Health (NIMH) Data Archive (NDA) using the data dictionaries available in NDA. As per NIMH Data Archive, data will be deidentified and assigned a Global Unique Identifier (GUID).
Informations sur les médicaments et les dispositifs, documents d'étude
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