Clinical trial NCT05918835: Effects of rTMS on Food Choice in Anorexia Nervosa
Official title: Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Repetitive Transcranial Magnetic Stimulation
Anorexia Nervosa
Restrictive Eating
Feeding and Eating Disorders
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Eating Disorders Association
name: Global Foundation for Eating Disorders
First posted: 2023-06-26
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.

Detailed description: Anorexia nervosa (AN) is a devastating illness with morbidity and mortality rates among the highest associated with any psychiatric disorder. Treatments for adults with AN have limited efficacy due to an inadequate understanding of the mechanisms underlying AN's core symptoms. The salient feature of AN is extreme restriction of food, particularly dietary fat intake, a behavior both highly resistant to change and central to relapse. Neuroimaging research of food restriction in AN has found that compared to healthy controls, patients with AN exhibit greater choice-related dorsal striatum activation and different connection strength within dorsal fronto-striatal circuits, suggesting that activity in this region and associated circuits may underlie maladaptive eating behavior. To confirm the significance of these brain regions in restrictive eating, this study will combine neuronavigation-guided high-frequency rTMS (HF-rTMS), individualized functional TMS targets, fMRI and a computerized food-choice task to test the effects of HF-rTMS on restrictive food choice and associated neural activity.

The study will utilize a double-blinded randomized parallel design: adult inpatients with AN will receive either HF-rTMS or sham to the DLPFC. We will compare group changes in brain and behavior to test whether activity in the dorsal striatum underlies restrictive eating behavior in AN and quantify the effects of HF-rTMS to the DLPFC on restrictive eating behavior. Our use of individualized TMS targets will enable us to identify whether resting-state functional connectivity predicts neural or behavioral response to HF-rTMS.

Eligibility criteria: Inclusion Criteria:

* DSM-5 Diagnosis of Anorexia Nervosa
* Age 18-30 years
* Female
* Right-handed
* Body Mass Index (BMI) ≥ 16.0
* Voluntarily admitted to inpatient eating disorders unit at NYSPI
* Competent to provide informed consent
* English-speaking
* Medically stable

Exclusion Criteria:

* High risk of suicide
* Current substance use disorder or other co- morbid psychiatric condition requiring specialized treatment (e.g., psychosis)
* Diagnosis of major medical or neurological problem or taking medication that significantly increases risk for seizure or affects interpretation of findings (e.g., unstable hypertension, seizure disorder)
* Food restrictions (e.g., allergies) which impact greater than 30% of food choice task's choice options
* Indwelling ferromagnetic metallic object (e.g., pacemaker, pump), non- removable metal jewelry, medicinal patch or recent metallic ink tattoo
* History of seizure
* Diagnosis of epilepsy, stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, or parenchymal or leptomeningeal cancers
* Prior exposure to TMS
* Pregnancy
* Currently breast-feeding
* Significant claustrophobia
* Implanted devices or stimulators
* Hearing loss (e.g., currently undergoing treatment with ototoxic medications or those with cochlear implants)

Primary outcomes:
measure: Neural activity and functional connectivity during the food choice task
timeFrame: Baseline to post-treatment (approx. 1 week apart)
measure: Restrictive eating behavior during the food choice task
timeFrame: Baseline to post-treatment (approx. 1 week apart)
Secondary outcomes:
measure: Predictors of HF-rTMS response
timeFrame: Baseline to post-treatment (approx. 1 week apart)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York Sate Psychiatric Institute
name: Alexandra F Muratore, PhD
role: PRINCIPAL_INVESTIGATOR
References: