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rTMS for Aneroxia Nervosa in Youth (MULTI-REX)

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ClinicalTrials.gov Identifier: NCT04846517
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew F. Leuchter, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Device: Transcranial Magnetic Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multilocus Repetitive Transcranial Magnetic Stimulation for Anorexia Nervosa (MULTI-REX): A 4-week Open-Trial Pilot Study
Estimated Study Start Date : June 30, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Arm Intervention/treatment
TMS 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

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



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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. YBC-EDS score≥16,
  3. baseline CGI-S score ≥4,
  4. English speaking (as this complement of questionnaires are available in English)
  5. 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),
  6. medically stable, as determined by their treating clinician, and
  7. 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.
  8. 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:

  1. a lifetime history of psychosis, mania, or seizure disorder
  2. 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.
  3. unstable neurological disorder,
  4. metal in head/eye,
  5. inability to tolerate MRI,
  6. at high risk of alcohol withdrawal or substance intoxication,
  7. diagnosis of pervasive development disorder,
  8. 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),
  9. For women: pregnant or not using a reliable form of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846517


Contacts
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Contact: Jonathan Lee, MD (310_824-0304 jonthanclee@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Andrew F. Leuchter, Assistant Professor- UCLA Neuromodulation Division, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04846517    
Other Study ID Numbers: 20-001905
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew F. Leuchter, University of California, Los Angeles:
AN
TMS
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders