Status:
ACTIVE_NOT_RECRUITING
Transcranial Magnetic Stimulation (TMS) in the Treatment of Anorexia Nervosa
Lead Sponsor:
University of California, San Diego
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Anorexia nervosa is a severe psychiatric disorder associated with food avoidance and body image distortion, that is feeling fat despite being underweight. It is the third most common chronic illness a...
Detailed Description
The goals for this study are 1) to test the feasibility of iTBS in AN and 2) to gather pilot data to as proof of concept of its effectiveness in AN prior to applying for larger funding to the NIH. Su...
Eligibility Criteria
Inclusion
- Females ages 18 to 45 years
- Diagnostic criteria. Current diagnosis of AN according to the DSM V, including having a severe fear of weight gain and body image distortion
- Restricting or binge/purge subtype
- English is primary language spoken
Exclusion
- Subjects who are pregnant or think they may be pregnant will be excluded from the study.
- Subjects will not have electrolyte, blood count or kidney or liver function abnormalities. Prior to starting the TMS treatment (Visit 2), all subjects will complete a basic metabolic panel (must be completed within no more than one week prior to the start of the TMS treatment) to rule out electrolyte or metabolic abnormalities.
- Subjects may not have a lifetime history of a condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event.
- Subjects may not have a history of significant head trauma with loss of consciousness for greater than 5 minutes.
- Subjects may not have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- Subjects may not currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit TMS efficacy or have a history of lack of response to accelerated course of iTBS or rTMS in the past.
- Subjects may not have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump.
- Subjects may not have symptoms of alcohol or substance abuse or dependence in the past month, may not have previous or current organic brain syndromes, psychotic disorders, bipolar type disorders, somatization disorders, or conversion disorder.
- Antidepressant bupropion or other seizure threshold lowering medication or are currently taking tricyclic antidepressants or neuroleptics.
- Permanent eye makeup (such as eyeliner or eyebrows) or other face tattoos due to potential ferrous materials used in the tattoo ink
- Subjects may not have a history of neurocardiogenic syncope as there is an increased risk of TMS-induced neurocardiogenic syncope in adolescent populations.
- Subjects may not have implanted neurostimulators, intracardiac lines, or heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology (including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV).
- Subjects may not have a history of stroke or other brain lesions.
- Subjects may not have a history of suicide attempt(s).
- Subject may not have a family history of epilepsy.
- Cannot refrain from drinking alcohol for the duration of the study. Subjects will be asked to refrain from consuming alcohol for the duration of the study. At the beginning of each treatment day subjects will be asked about alcohol consumption in the last 48 hours and will not complete the treatment sessions that day if they have had alcohol in the last 48 hours.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05368844
Start Date
June 16 2022
End Date
October 1 2026
Last Update
September 2 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92121