TMS + Exposure Therapy for Pediatric OCD
A legfontosabb adatok
- Ki végzi
- Bradley Hospital
- Hol
- Minneapolis és Riverside (Egyesült Államok)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 59 fő vett részt
- Kezdés
- 2024. márc. 20.
- Befejezés
- 2026. júl. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex
- Exposure with Response Prevention
- Transcranial Magnetic Stimulation: Sham
- Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
- A regiszteradat frissítve
- 2026. október 19.
Ki vehet részt
- Életkor
- 12 év – 21 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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)
- 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
- History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture)
- Decline to provide informed consent
- 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
- Left handedness
- 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
Helyszínek itt: Egyesült Államok
- University of MinnesotaMinneapolis, Egyesült Államok
- Emma Pendleton Bradley HospitalRiverside, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this clinical trial is to compare different forms of 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 three groups: ERP with one of two different active ("real") forms of TMS vs. ERP with sham ("fake") TMS. The main questions this study aims to answer are: 1) whether TMS normalizes functioning in brain circuits that contribute to compulsive behavior, and 2) whether TMS reduces compulsions during ERP. Participants will:
A teljes eredeti leírásKevesebb
* Complete clinical interviews, questionnaires, and computerized tasks * Complete two MRIs (brain scans) * Receive daily TMS followed by ERP for two weeks (10 sessions)
A vizsgálat 3 csoportja
- ERP+iTBSA vizsgált kezelés
Participants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).
Kezelés: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex és Exposure with Response Prevention
- ERP+cTBSA vizsgált kezelés
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).
Kezelés: Exposure with Response Prevention és Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
- ERP+ShamMár használt kezelés, összehasonlításként
Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
Kezelés: Exposure with Response Prevention és Transcranial Magnetic Stimulation: Sham
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
- A regiszteradat frissítve
- 2026. október 19.