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)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kristen Benito, PhD
- Telefonnummer: 4014321054
- E-mail: kbenito@brownhealth.org
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55414
- Rekruttering
- University of Minnesota
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Kontakt:
- Christine Conelea, PhD
- Telefonnummer: 612-261-3127
- E-mail: cconelea@umn.edu
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02915
- Rekruttering
- Emma Pendleton Bradley Hospital
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Kontakt:
- Kristen Benito, PhD
- Telefonnummer: 4014321054
- E-mail: kbenito@brownhealth.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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
Andre navne:
ERP will be delivered daily, immediately following TMS
Andre navne:
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Aktiv komparator: 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
Andre navne:
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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Global Impressions Scale-Improvement
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kristen Benito, PhD, Emma Pendleton Bradley Hospital
- Ledende efterforsker: Christine Conelea, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Impulsiv adfærd
- Opførsel
- Kompulsiv adfærd
- Terapeutik
- Fysioterapimodaliteter
- Adfærdsterapi
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Rehabilitering
- Anæstesi og analgesi
- Elektrisk stimuleringsterapi
- Analgesi
- Desensibilisering, psykologisk
- Kognitiv adfærdsterapi
- Transkutan elektrisk nervestimulering
- Implosiv terapi
Andre undersøgelses-id-numre
- 2113426
- R33MH133666 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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).
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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