An interventional study of High-frequency repetitive transcranial magnetic stimulation (active rTMS) and Sham repetitive transcranial magnetic stimulation (sham rTMS) in Anorexia Nervosa, sponsored by New York State Psychiatric Institute. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Basic science
This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.
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.
455 studies on the registry are indexed under Anorexia Nervosa; 126 are open to participants now.
This study's planned enrollment of 72 is above the median of 44 across 305 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
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
Device: High-frequency repetitive transcranial magnetic stimulation (active rTMS)
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
Device: Sham repetitive transcranial magnetic stimulation (sham 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).
Also known as: Magstim TMS System active coil, High-frequency rTMS, Repetitive Transcranial Magnetic Stimulation
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).
Also known as: Magstim TMS System sham coil, Sham rTMS
Neural activity and functional connectivity during the food choice task
Change in: food choice-related BOLD activity within the dorsal striatum, food choice-related functional Change in: connectivity between the dorsal striatum and dorsolateral prefrontal cortex
Time frame: Baseline to post-treatment (approx. 1 week apart)
Restrictive eating behavior during the food choice task
Change in: proportion of high-fat foods selected; proportion of trials in which participants had an opportunity to implement self-control; proportion of trials in which participants implemented self-control
Time frame: Baseline to post-treatment (approx. 1 week apart)
Predictors of HF-rTMS response
Association between resting-state functional connectivity and: neural activity and functional connectivity during the food choice task (primary outcome #1); restrictive eating behavior during the food choice task (primary outcome #2)
Time frame: Baseline to post-treatment (approx. 1 week apart)
Plan to share: No
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New York State Psychiatric Institute