Anorexia NervosaNCT05918835
Effects of rTMS on Food Choice in Anorexia Nervosa
A study testing High-frequency repetitive transcranial magnetic stimulation (active rTMS) in people with Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- High-frequency repetitive transcranial magnetic stimulation (active rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 Diagnosis of Anorexia Nervosa
- Age 18-35 years
- Female
- Right-handed
- Body Mass Index (BMI) ≥ 16.0
- Voluntarily admitted to inpatient eating disorders unit at NYSPI
Show all 9Show fewer
- Competent to provide informed consent
- English-speaking
- Medically stable
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York State Psychiatric Institute
New York, New York, 10032
Alexandra F Muratore, PhD, 646-774-8053, afm2166@cumc.columbia.edu
About this study
Official title: Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation
This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.
Read the 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
- Being tested
- High-frequency repetitive transcranial magnetic stimulation (active rTMS), Sham repetitive transcranial magnetic stimulation (sham rTMS)
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Anorexia Nervosa, Restrictive Eating, Feeding and Eating Disorders
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency repetitive transcranial magnetic stimulation (active rTMS)Device
Also called Magstim TMS System active coil, High-frequency rTMS, Repetitive Transcranial Magnetic Stimulation
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 repetitive transcranial magnetic stimulation (sham rTMS)Device
Also called Magstim TMS System sham coil, 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham repetitive transcranial magnetic stimulation (sham rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to post-treatment (approx. 1 week apart)
Secondary outcomes (1)
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)
Measured: Baseline to post-treatment (approx. 1 week apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start24 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Eating Disorders Association, Global Foundation for Eating Disorders
- Responsible party
- Principal investigator, Alexandra F Muratore, PhD, New York State Psychiatric Institute
- Investigators
- Alexandra F Muratore, PhD, Principal investigator, New York Sate Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918835
- Sponsor's protocol ID
- #8338
- Other IDs
- 1K23MH128530
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Neural Mechanisms of Restrictive Eating in Anorexia Nervosa Using Repetitive Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT05918835
- Acronym / sponsor ID
- #8338
- Conditions
- Anorexia Nervosa
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Anorexia Nervosa, Restrictive Eating, Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Eating Disorders Association, Global Foundation for Eating Disorders
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) | Experimental | 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: 10 pulses/sec, 4s trains, 120% MT, 3000 pulses/session |
| Sham repetitive transcranial magnetic stimulation (sham rTMS) | Sham comparator | Device: Sham repetitive transcranial magnetic stimulation (sham 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- DSM-5 Diagnosis of Anorexia Nervosa
- Age 18-35 years
- Female
- Right-handed
- Body Mass Index (BMI) ≥ 16.0
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency repetitive transcranial magnetic stimulation (active rTMS)Also: Magstim TMS System active coil, High-frequency rTMS, Repetitive Transcranial Magnetic StimulationHF-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 | High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) |
| Sham repetitive transcranial magnetic stimulation (sham rTMS)Also: Magstim TMS System sham coil, Sham rTMSSham 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). | Device | Sham repetitive transcranial magnetic stimulation (sham rTMS) |
Primary outcome
Neural activity and functional connectivity during the food choice task
Time frame: Baseline to post-treatment (approx. 1 week apart)
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
Restrictive eating behavior during the food choice task
Time frame: Baseline to post-treatment (approx. 1 week apart)
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
1 secondary outcome
Predictors of HF-rTMS response
Time frame: Baseline to post-treatment (approx. 1 week apart)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra F Muratore, PhD principal investigator
New York Sate Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency repetitive transcranial magnetic stimulation (active rTMS) in people with Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra F Muratore, PhD (646-774-8053, afm2166@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural activity and functional connectivity during the food choice task (time frame: Baseline to post-treatment (approx. 1 week apart)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.