NCT05918835

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Apr 2023Jun 2028

Study Start

First participant enrolled

April 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5.2 years

First QC Date

June 16, 2023

Last Update Submit

February 20, 2026

Conditions

Keywords

Repetitive Transcranial Magnetic StimulationAnorexia NervosaRestrictive EatingFeeding and Eating Disorders

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)

EXPERIMENTAL

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)

Sham repetitive transcranial magnetic stimulation (sham rTMS)

SHAM COMPARATOR

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)

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).

Also known as: Magstim TMS System active coil, High-frequency rTMS, Repetitive Transcranial Magnetic Stimulation
High-frequency repetitive transcranial magnetic stimulation (HF-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).

Also known as: Magstim TMS System sham coil, Sham rTMS
Sham repetitive transcranial magnetic stimulation (sham rTMS)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Alexandra F Muratore, PhD

    New York Sate Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra F Muratore, PhD

CONTACT

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

Locations