rTMS for Aneroxia Nervosa in Youth

Anorexia Nervosa Clinical Trial

— MULTI-REX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04846517
• Other study ID #: 20-001905
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: University of California, Los Angeles
• Contact: Jonathan Lee, MD
• Phone: (310_824-0304
• Email: jonthanclee[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 6 weeks