Effects of rTMS on Food Choice in Anorexia Nervosa

New York State Psychiatric Institute

Status: Suspended

Conditions: Anorexia Nervosa

Treatments: Device: Sham repetitive transcranial magnetic stimulation (sham rTMS); Device: High-frequency repetitive transcranial magnetic stimulation (active rTMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05918835

1K23MH128530 (U.S. NIH Grant/Contract)

#8338

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS)

Experimental group

Description:

Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: 10 pulses/sec, 4s trains, 120% MT, 3000 pulses/session

Treatment:

Device: High-frequency repetitive transcranial magnetic stimulation (active rTMS)

Sham repetitive transcranial magnetic stimulation (sham rTMS)

Sham Comparator group

Description:

Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: same as HF-rTMS, with sham coil

Treatment:

Device: Sham repetitive transcranial magnetic stimulation (sham rTMS)