Effects of rTMS on Food Choice in Anorexia Nervosa
Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation
2 other identifiers
interventional
72
1 country
1
Brief Summary
This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2023
CompletedFirst Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 23, 2026
February 1, 2026
5.2 years
June 16, 2023
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Baseline to post-treatment (approx. 1 week apart)
Secondary Outcomes (1)
Predictors of HF-rTMS response
Baseline to post-treatment (approx. 1 week apart)
Study Arms (2)
High-frequency repetitive transcranial magnetic stimulation (HF-rTMS)
EXPERIMENTALTarget: 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
Sham repetitive transcranial magnetic stimulation (sham rTMS)
SHAM COMPARATORTarget: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: same as HF-rTMS, with sham coil
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- National Institute of Mental Health (NIMH)collaborator
- National Eating Disorders Associationcollaborator
- Global Foundation for Eating Disorderscollaborator
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra F Muratore, PhD
New York Sate Psychiatric Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Medical Psychology (in Psychiatry)
Study Record Dates
First Submitted
June 16, 2023
First Posted
June 26, 2023
Study Start
April 24, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share