Phase
Condition
Anorexia
Vomiting
Treatment
rTMS treatment using BrainsWay Model 104 system with H1-Coil
sham TMS using BrainsWay Model 104 system with H1-Coil
Clinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females ages 18 to 45 years
Diagnostic criteria. Current diagnosis of AN according to the DSM V, includinghaving a severe fear of weight gain and body image distortion
Restricting or binge/purge subtype
English is primary language spoken
Exclusion
Exclusion Criteria:
Subjects who are pregnant or think they may be pregnant will be excluded from thestudy.
Subjects will not have electrolyte, blood count or kidney or liver functionabnormalities. Prior to starting the TMS treatment (Visit 2), all subjects willcomplete a basic metabolic panel (must be completed within no more than one weekprior to the start of the TMS treatment) to rule out electrolyte or metabolicabnormalities.
Subjects may not have a lifetime history of a condition likely to be associated withincreased intracranial pressure, space occupying brain lesion, any history ofseizure except those therapeutically induced by ECT or a febrile seizure of infancyor single seizure related to a known drug related event.
Subjects may not have a history of significant head trauma with loss ofconsciousness 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 ornear the head, excluding the mouth, that cannot be safely removed.
Subjects may not currently take more than lorazepam 2 mg daily (or equivalent) orany dose of an anticonvulsant due to the potential to limit TMS efficacy or have ahistory of lack of response to accelerated course of iTBS or rTMS in the past.
Subjects may not have a concomitant major unstable medical illness, cardiacpacemaker or implanted medication pump.
Subjects may not have symptoms of alcohol or substance abuse or dependence in thepast month, may not have previous or current organic brain syndromes, psychoticdisorders, bipolar type disorders, somatization disorders, or conversion disorder.
Antidepressant bupropion or other seizure threshold lowering medication or arecurrently taking tricyclic antidepressants or neuroleptics.
Permanent eye makeup (such as eyeliner or eyebrows) or other face tattoos due topotential ferrous materials used in the tattoo ink
Subjects may not have a history of neurocardiogenic syncope as there is an increasedrisk of TMS-induced neurocardiogenic syncope in adolescent populations.
Subjects may not have implanted neurostimulators, intracardiac lines, or heartdisease that causes moderate to severe symptoms and/or is characterized by moderateto severe pathology (including a recent history of myocardial infarction and heartfailure with an ejection fraction of less than 30% or with a New York HeartAssociation 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 beasked to refrain from consuming alcohol for the duration of the study. At thebeginning of each treatment day subjects will be asked about alcohol consumption inthe last 48 hours and will not complete the treatment sessions that day if they havehad alcohol in the last 48 hours.
Study Design
Study Description
Connect with a study center
University of California San Diego
San Diego, California 92121
United StatesSite Not Available
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