NCT05918835

Effects of rTMS on Food Choice in Anorexia Nervosa

Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DEVICE	High-frequency repetitive transcranial magnetic stimulation (active rTMS)	HF-rTMS is applied with a figure-of-8 coil using the Magstim TMS System. Participants receive one administration of HF-rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). HF-rTMS is delivered at a frequency of 10 Hz for approximately 37 minutes (3000 total pulses).
DEVICE	Sham repetitive transcranial magnetic stimulation (sham rTMS)	Sham rTMS is applied with a figure-of-8 sham coil using the Magstim TMS System, which is identical to the active coil, replicates the sounds of HF-rTMS, and is designed to mimic sensations of HF-rTMS. Participants receive one administration of sham rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). Sham rTMS is delivered for approximately 37 minutes (3000 total pulses).

Timeline

• Start date: 2023-04-24
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2023-06-26
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study