rTMS for Aneroxia Nervosa in Youth

ConditionAnorexia Nervosa

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14-24

SponsorUniversity of California, Los Angeles

About this trial

This study will examine the feasibility of off-label multilocus repetitive transcranial magnetic stimulation (rTMS) for symptoms of Anorexia Nervosa in participants between the ages of 14-24. rTMS is a non-invasive, brain-based intervention that uses magnets to deliver energy to the brain. The investigators will also see if patients receiving multilocus rTMS show any improvements in their eating disorder, mood, anxiety, and obsessions and compulsions (if present). Participants will receive daily intervention with off-label multilocus rTMS for 20 total treatments. Participants will also be asked to complete mental health and well-being surveys, physical measurements, and 2 brain imagining scans (MRIs) at baseline, and at study end. The investigators will also ask participants to complete surveys are 1-month and 3-months after the final rTMS session. The target enrollment for this study is 45 participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

youth aged 14-24 with DSM-5 AN-restricting (ANR) or AN-binge-eating-purging (ANBP) type as determined by the MINI-KID/MINI and clinical interview;

YBC-EDS score≥16,

baseline CGI-S score ≥4,

English speaking (as this complement of questionnaires are available in English)

Disqualifiers

a lifetime history of psychosis, mania, or seizure disorder

active suicidality as determined by clinical assessment by MD or PhD, and endorsement of items 4 or 5 on the Severity of Ideation Subscale of the C-SSRS.

unstable neurological disorder,

metal in head/eye,

Trial design

Design model

Single group

Treatments tested in this trial

Transcranial Magnetic Treatment
Device
iTBS treatment: Trains of 50 Hz pulses every 200 ms lasting 2 s, with an 8 s intertrain interval (ITI), repeated 60 times 1800 total pulses each day Treatment Duration: 9 minutes Location: Left DLPFC LF-rTMS treatment: Delivered immediately after iTBS treatment as described above. SMA will involve a continuous train of 1 Hz stimulation for a total of 1200 pulses lasting 20 minutes Treatment Duration: 20 minutes Location: SMA

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: TMS TreatmentOther 1 intervention

Trial outcomes

Primary outcomes

Change in Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)

The YBC-EDS consists of a 65-item symptom checklist, followed by 19 questions. Although the thoughts and behaviors included in the YBC-EDS symptom checklist are fairly extensive, patients may add any eating-related thoughts or behaviors that are not part of the checklist. Once the preoccupations and rituals checklists have been completed, four core questions are then asked regarding preoccupations and four regarding rituals, yielding a Preoccupations Subtotal, Rituals Subtotal, and a YBC-EDS Total Score. A provisional score assessing the patient's motivation for change can also be calculated, and has shown to be an important predictor of treatment outcome. The YBC-EDS Interview takes between 45-60 minutes to administer.

Time frame

through study completion, an average of 6 weeks

Locations

This trial has no locations.

Sponsors and contacts

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

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov

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