Menu
Not yet recruiting NCT04846517

rTMS for Aneroxia Nervosa in Youth

No phase Interventional Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Treatment.
Who it may be relevant to
Registry conditions: Anorexia Nervosa. Basic parameters: 14 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multilocus Repetitive Transcranial Magnetic Stimulation for Anorexia Nervosa (MULTI-REX): A 4-week Open-Trial Pilot Study

Overview

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.

Interventions

  • Device Transcranial Magnetic Treatment
    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

Primary outcome measures

  • Change in Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) [Time frame: through study completion, an average of 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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)
  • on stable psychotropic medication (if any) for the preceding 4 weeks (i.e., SSRIs, atypical antipsychotics and benzodiazepines of doses <1 mg lorazepam equivalent daily),
  • medically stable, as determined by their treating clinician, and
  • not deemed to be at high risk of imminent suicidal behavior by initial study psychiatrist assessment and referring provider/team, and no endorsement of items 4 or 5 on the Severity of Ideation Subscale of the C-SSRS.
  • For women: not currently pregnant and on reliable birth control if sexually active (as the effects of rTMS on the unborn fetus are unknown).

Exclusion criteria

  • 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,
  • inability to tolerate MRI,
  • at high risk of alcohol withdrawal or substance intoxication,
  • diagnosis of pervasive development disorder,
  • medical instability as determined by primary care provider and/or referring clinician (i.e., unstable electrolytes in the setting of worsening binge-eating/purging, cardiac arrhythmias requiring Holter or other intensive monitoring),
  • For women: pregnant or not using a reliable form of birth control.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04846517 · 20-001905

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗