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TMS + Exposure Therapy for Pediatric OCD: Second Phase

ConditionObsessive Compulsive Behavior
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorBradley Hospital

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

    Device

    TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern

  • Transcranial Magnetic Stimulation: Sham

    Device

    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

  • Exposure with Response Prevention

    Behavioral

    ERP will be delivered daily, immediately following TMS

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ERP+cTBSExperimental treatment 2 interventions
Group B: ERP+ShamActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit

correlation coefficient representing resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)

Time frame
two weeks (post-treatment)
2

Observed Compulsive Behavior

Duration of time during which compulsions are observed during ERP sessions

Time frame
two weeks
3

Child/Adult Yale-Brown Obsessive Compulsive Inventory

Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale

Time frame
six weeks (1-month follow-up)

Secondary outcomes

1

Clinical Global Impressions Scale-Improvement

Independent-Evaluator (IE) rated measure of clinical improvement. Rated on 1 (very much improved) to 7 (very much worse) scale

Time frame
six weeks (1-month follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bradley Hospital

Lead sponsor

University of Minnesota

Collaborator

Butler Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: