Anorexia NervosaRestrEATNCT07860320
Circuit-Guided Neuromodulation for Anorexia Nervosa
A study testing Intermittent theta-burst stimulation (iTBS) and Continuous theta-burst stimulation (cTBS) in people with Anorexia Nervosa, run by Fundacao Champalimaud at 1 site in Portugal.
Trial summary
The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Intermittent theta-burst stimulation (iTBS) and Continuous theta-burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2026to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, inclusive.
- Established diagnosis of anorexia nervosa according to DSM-5 criteria, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) at Visit 1.
- Capacity to provide written informed consent, as assessed by the investigator at Visit 1.
- Fluency in European Portuguese sufficient to complete the study assessments.
Who cannot join
- Current manic or psychotic episode.
- Major or minor neurocognitive disorder.
- Neurodevelopmental disorder, including attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD).
- Any medical or psychiatric condition requiring immediate hospitalization at the time of enrollment. Psychiatry day hospital care does not constitute an exclusion criterion.
- History of a structural lesion of the central nervous system.
- Presence of electrical or metallic implants incompatible with TMS or MRI, including cochlear implants, deep brain stimulators, vagus nerve stimulators, cardiac pacemakers, implantable cardioverter-defibrillators, intracardiac lines, or aneurysm clips or coils, in accordance with the manufacturer's contraindications.
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- Personal history of epilepsy or unexplained loss of consciousness.
- Any contraindication to TMS or MRI.
- Pregnancy or breastfeeding at the time of enrollment.
- For participants of childbearing potential, lack of use of an effective method of contraception throughout the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Champalimaud Foundation
Lisbon, Lisbon District, 1400-038
Gonçalo Cotovio, MD, PhD, +351 210 480 200, goncalo.cotovio@neuro.fchampalimaud.org
Gonçalo Cotovio, MD, PhD
About this study
Official title: Re-tuning Restrictive Eating Circuits: From Lesion Network Mapping to Personalized Neuromodulation Targets
The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa.
The main questions this study aims to answer are:
Read more
- Does personalized transcranial magnetic stimulation (TMS) change functional connectivity within a brain network related to restrictive eating compared with sham stimulation?
- Do different types of TMS affect measures related to inhibitory control, body image, eating-disorder symptoms, mood, and anxiety, and are they safe and well tolerated?
Participants will:
- Attend four study visits, separated by at least one week.
- Complete clinical and psychological assessments and undergo brain magnetic resonance imaging (MRI).
- Receive three stimulation conditions in random order at separate visits: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation.
- Complete brain MRI scans and research tasks so that the effects of the three stimulation conditions can be compared.
Researchers will compare the effects of iTBS and cTBS with sham stimulation on brain connectivity and other study measures.
This is an exploratory proof-of-concept study designed to test whether personalized brain stimulation can engage the targeted brain circuit. It is not designed to determine whether TMS is an effective treatment for anorexia nervosa, and direct clinical benefit to participants is not expected.
Read the detailed description
RestrEAT is a mechanistic, proof-of-concept investigation designed to evaluate a personalized, circuit-guided targeting strategy for prefrontal theta-burst stimulation (TBS) in anorexia nervosa.
The targeting framework is based on a lesion-defined restrictive-eating network derived from brain lesions associated with restrictive eating and anorexia-nervosa-like psychopathology. For each participant, individualized electric-field modelling using SimNIBS is combined with functional connectivity derived from the participant's baseline fMRI data. Candidate TMS-accessible prefrontal sites are evaluated, and the stimulation site is selected according to the similarity between its individual functional connectivity profile and the lesion-defined network. The individualized target is subsequently implemented using neuronavigation.
The study is intended to generate mechanistic target-engagement data rather than establish the therapeutic efficacy of TMS for anorexia nervosa. The within-subject crossover design was selected because the effects of a single TBS session are expected to be acute and transient, allowing comparison of stimulation conditions within the same participant while reducing variability related to inter-individual differences in functional connectivity and cognitive performance.
The results are intended to evaluate the feasibility and biological validity of the personalized targeting approach, characterize effect-size estimates, and inform the design of a subsequent adequately powered therapeutic clinical trial if supported by the findings.
- Conditions
- Anorexia Nervosa
- Being tested
- Intermittent theta-burst stimulation (iTBS), Continuous theta-burst stimulation (cTBS), Sham theta-burst stimulation
- Keywords
- Eating Disorders, Restrictive Eating, Brain Mapping, Personalized Neuromodulation, Functional Connectivity, Lesion Network Mapping, Transcranial Magnetic Stimulation
- 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.
Intermittent theta-burst stimulation (iTBS)Device
A single session of neuronavigated intermittent theta-burst stimulation (iTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, in an intermittent pattern of 2 seconds ON and 8 seconds OFF, for a total of 600 pulses over approximately 190 seconds.
Continuous theta-burst stimulation (cTBS)Device
A single session of neuronavigated continuous theta-burst stimulation (cTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, continuously without interruption, for a total of 600 pulses over approximately 40 seconds.
Sham theta-burst stimulationDevice
A single session of sham theta-burst stimulation is delivered using the MagVenture MagPro X100 with MagOption and a shielded sham coil at the individualized prefrontal target. Coil positioning, neuronavigation display, and auditory and somatosensory characteristics are matched as closely as possible to the active conditions. The programmed sham protocol uses 5-Hz bursts with 3 pulses at 50 Hz per burst, an intermittent pattern of 5 seconds ON and 10 seconds OFF, 600 pulses, a session duration of 110 seconds, and an intensity setting of 80% of the individual RMT.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Theta-Burst Stimulation (iTBS) | Experimental | Participants receive one session of personalized prefrontal intermittent theta-burst stimulation (iTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. Receives: Device: Intermittent theta-burst stimulation (iTBS) |
| Continuous Theta-Burst Stimulation (cTBS) | Experimental | Participants receive one session of personalized prefrontal continuous theta-burst stimulation (cTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. Receives: Device: Continuous theta-burst stimulation (cTBS) |
| Sham Theta-Burst Stimulation | Sham comparator | Participants receive one session of sham theta-burst stimulation during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. Receives: Device: Sham theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Stimulation Target-to-Network Resting-State fMRI Functional Connectivity
Resting-state fMRI functional connectivity between the individualized prefrontal stimulation target and the lesion-defined restrictive-eating network, quantified using the target-to-network connectivity index. The measure is assessed after each iTBS, cTBS, and sham session and compared within participants across the three stimulation conditions.
Measured: Within approximately 30 minutes after each stimulation session at crossover Visits 2, 3, and 4 (Weeks 2, 4, and 6; visits separated by at least 1 week)
Secondary outcomes (4)
GNAT Inhibitory-Control Performance (d-prime) After Stimulation
Inhibitory-control performance assessed using the Go/No-Go Association Task (GNAT) with food and non-food stimuli. The pre-specified outcome metric is d-prime, assessed following each stimulation condition and compared within participants across iTBS, cTBS, and sham.
Measured: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Body Discrepancy Index After Stimulation
Body-image evaluation assessed using a 7-silhouette body-image task adapted for scanner administration. The primary metric is the body discrepancy index, based on the difference between perceived and ideal body silhouettes, and is compared within participants across iTBS, cTBS, and sham conditions.
Measured: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Post-Stimulation Task-Based fMRI BOLD Signal in the Lesion-Defined Network
Blood-oxygen-level-dependent (BOLD) signal measured in pre-specified regions of interest within the lesion-defined restrictive-eating network during the GNAT and body-image task paradigms. BOLD responses are compared within participants across iTBS, cTBS, and sham conditions.
Measured: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Eating Disorder Psychopathology Assessed With the EDE-Q
Eating-disorder psychopathology assessed using the Eating Disorder Examination Questionnaire (EDE-Q), version 6.0. The pre-specified metric is the EDE-Q total score. Higher scores indicate greater eating-disorder psychopathology. The EDE-Q is administered before stimulation at each crossover visit.
Measured: Pre-stimulation at crossover Visits 2, 3, and 4 (approximately Weeks 2, 4, and 6; visits separated by at least 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- Each participant receives all three stimulation conditions (iTBS, cTBS, and sham) in randomized order across three separate crossover stimulation visits, with a washout interval of at least one week between visits. Each participant therefore serves as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gonçalo Cotovio, MD, PhD, Principal investigator, Champalimaud FoundationAlbino J. Oliveira-Maia, MD, MPH, PhD, Study director, Champalimaud Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860320
- Sponsor's protocol ID
- RestrEAT
- Other IDs
- 723209, 2626CI_RESTREAT
- Acronym
- RestrEAT
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data (IPD) or associated data dictionaries available to external researchers. Any future data-sharing proposal would be considered on a case-by-case basis and would require appropriate authorization by the Sponsor and Data Protection Officer and compliance with applicable data-protection requirements.
Publications
Cotovio G, Oliveira-Maia AJ. Functional neuroanatomy of mania. Transl Psychiatry. 2022 Jan 24;12(1):29. doi: 10.1038/s41398-022-01786-4.
PubMed 35075120Cotovio G, Seybert C, Rodrigues da Silva D, Faro Viana F, Estrela JP, Pereira P, Oliveira-Maia AJ. Conventional Repetitive Transcranial Magnetic Stimulation for Depression: A Step-by-Step Protocol. J Vis Exp. 2025 Nov 21;(225). doi: 10.3791/68891.
PubMed 41359596Cotovio G, Ventura F, Rodrigues da Silva D, Pereira P, Oliveira-Maia AJ. Regulatory Clearance and Approval of Therapeutic Protocols of Transcranial Magnetic Stimulation for Psychiatric Disorders. Brain Sci. 2023 Jul 5;13(7):1029. doi: 10.3390/brainsci13071029.
PubMed 37508962Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
PubMed 21727255Soeby M, Gribsholt SB, Clausen L, Richelsen B. Overall and cause-specific mortality in anorexia nervosa; impact of psychiatric comorbidity and sex in a 40-year follow-up study. Int J Eat Disord. 2024 Sep;57(9):1842-1853. doi: 10.1002/eat.24223. Epub 2024 Jun 12.
PubMed 38863340Wonderlich SA, Bulik CM, Schmidt U, Steiger H, Hoek HW. Severe and enduring anorexia nervosa: Update and observations about the current clinical reality. Int J Eat Disord. 2020 Aug;53(8):1303-1312. doi: 10.1002/eat.23283. Epub 2020 May 2.
PubMed 32359125Zipfel S, Giel KE, Bulik CM, Hay P, Schmidt U. Anorexia nervosa: aetiology, assessment, and treatment. Lancet Psychiatry. 2015 Dec;2(12):1099-111. doi: 10.1016/S2215-0366(15)00356-9. Epub 2015 Oct 27.
PubMed 26514083Treasure J, Zipfel S, Micali N, Wade T, Stice E, Claudino A, Schmidt U, Frank GK, Bulik CM, Wentz E. Anorexia nervosa. Nat Rev Dis Primers. 2015 Nov 26;1:15074. doi: 10.1038/nrdp.2015.74.
PubMed 27189821Lakritz C, Iceta S, Duriez P, Makdassi M, Masetti V, Davidenko O, Lafraire J. Measuring implicit associations between food and body stimuli in anorexia nervosa: a Go/No-Go Association Task. Eat Weight Disord. 2023 Nov 2;28(1):93. doi: 10.1007/s40519-023-01621-9.
PubMed 37917374Wu K, Lo YT, Cavaleri J, Bergosh M, Ipe J, Briggs RG, Jann KB, Murray SB, Mason XL, Liu CY, Lee DJ. Neuromodulation of Eating Disorders: A Review of Underlying Neural Network Activity and Neuromodulatory Treatments. Brain Sci. 2024 Feb 22;14(3):200. doi: 10.3390/brainsci14030200.
PubMed 38539589Longo P, Bevione F, Lacidogna MC, Lavalle R, Abbate Daga G, Preti A. Neuromodulatory techniques in eating disorders: From electroconvulsive therapy to transcranial magnetic stimulation and beyond: A mixed method systematic meta-review. Psychiatry Res. 2025 Feb;344:116346. doi: 10.1016/j.psychres.2024.116346. Epub 2024 Dec 27.
PubMed 39740315Takahashi S, Ikeda S, Ueda M, Harada T, Ishii R. rTMS Therapy for Eating Disorders: Scoping Review on Efficacy, Safety, Stimulation Parameters and Study Subjects. Eur Eat Disord Rev. 2026 Mar;34(2):464-475. doi: 10.1002/erv.70046. Epub 2025 Oct 29.
PubMed 41163241Dalton B, Maloney E, Rennalls SJ, Bartholdy S, Kekic M, McClelland J, Campbell IC, Schmidt U, O'Daly OG. A pilot study exploring the effect of repetitive transcranial magnetic stimulation (rTMS) treatment on cerebral blood flow and its relation to clinical outcomes in severe enduring anorexia nervosa. J Eat Disord. 2021 Jul 9;9(1):84. doi: 10.1186/s40337-021-00420-w.
PubMed 34243816Bartholdy S, McClelland J, Kekic M, O'Daly OG, Campbell IC, Werthmann J, Rennalls SJ, Rubia K, David AS, Glennon D, Kern N, Schmidt U. Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial. Trials. 2015 Dec 3;16:548. doi: 10.1186/s13063-015-1069-3.
PubMed 26634828McClelland J, Kekic M, Bozhilova N, Nestler S, Dew T, Van den Eynde F, David AS, Rubia K, Campbell IC, Schmidt U. A Randomised Controlled Trial of Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Anorexia Nervosa. PLoS One. 2016 Mar 23;11(3):e0148606. doi: 10.1371/journal.pone.0148606. eCollection 2016.
PubMed 27008620
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-tuning Restrictive Eating Circuits: From Lesion Network Mapping to Personalized Neuromodulation Targets
- ClinicalTrials.gov ID
- NCT07860320
- Acronym / sponsor ID
- RestrEAT / RestrEAT
- Conditions
- Anorexia Nervosa
- Keywords
- Eating Disorders, Restrictive Eating, Brain Mapping, Personalized Neuromodulation, Functional Connectivity, Lesion Network Mapping, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
The goal of this clinical trial is to find out whether personalized, non-invasive brain stimulation can temporarily change communication within brain networks related to restrictive eating in adults with anorexia nervosa.
The main questions this study aims to answer are:
- Does personalized transcranial magnetic stimulation (TMS) change functional connectivity within a brain network related to restrictive eating compared with sham stimulation?
- Do different types of TMS affect measures related to inhibitory control, body image, eating-disorder symptoms, mood, and anxiety, and are they safe and well tolerated?
Participants will:
- Attend four study visits, separated by at least one week.
- Complete clinical and psychological assessments and undergo brain magnetic resonance imaging (MRI).
- Receive three stimulation conditions in random order at separate visits: intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), and sham stimulation.
- Complete brain MRI scans and research tasks so that the effects of the three stimulation conditions can be compared.
Researchers will compare the effects of iTBS and cTBS with sham stimulation on brain connectivity and other study measures.
This is an exploratory proof-of-concept study designed to test whether personalized brain stimulation can engage the targeted brain circuit. It is not designed to determine whether TMS is an effective treatment for anorexia nervosa, and direct clinical benefit to participants is not expected.
Detailed description
RestrEAT is a mechanistic, proof-of-concept investigation designed to evaluate a personalized, circuit-guided targeting strategy for prefrontal theta-burst stimulation (TBS) in anorexia nervosa.
The targeting framework is based on a lesion-defined restrictive-eating network derived from brain lesions associated with restrictive eating and anorexia-nervosa-like psychopathology. For each participant, individualized electric-field modelling using SimNIBS is combined with functional connectivity derived from the participant's baseline fMRI data. Candidate TMS-accessible prefrontal sites are evaluated, and the stimulation site is selected according to the similarity between its individual functional connectivity profile and the lesion-defined network. The individualized target is subsequently implemented using neuronavigation.
The study is intended to generate mechanistic target-engagement data rather than establish the therapeutic efficacy of TMS for anorexia nervosa. The within-subject crossover design was selected because the effects of a single TBS session are expected to be acute and transient, allowing comparison of stimulation conditions within the same participant while reducing variability related to inter-individual differences in functional connectivity and cognitive performance.
The results are intended to evaluate the feasibility and biological validity of the personalized targeting approach, characterize effect-size estimates, and inform the design of a subsequent adequately powered therapeutic clinical trial if supported by the findings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant receives all three stimulation conditions (iTBS, cTBS, and sham) in randomized order across three separate crossover stimulation visits, with a washout interval of at least one week between visits. Each participant therefore serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Theta-Burst Stimulation (iTBS) | Experimental | Device: Intermittent theta-burst stimulation (iTBS)Participants receive one session of personalized prefrontal intermittent theta-burst stimulation (iTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. |
| Continuous Theta-Burst Stimulation (cTBS) | Experimental | Device: Continuous theta-burst stimulation (cTBS)Participants receive one session of personalized prefrontal continuous theta-burst stimulation (cTBS) during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. |
| Sham Theta-Burst Stimulation | Sham comparator | Device: Sham theta-burst stimulationParticipants receive one session of sham theta-burst stimulation during one of the three randomized crossover stimulation visits. Each participant receives this condition once, with a washout interval of at least one week between stimulation visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years, inclusive.
- Established diagnosis of anorexia nervosa according to DSM-5 criteria, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) at Visit 1.
- Capacity to provide written informed consent, as assessed by the investigator at Visit 1.
- Fluency in European Portuguese sufficient to complete the study assessments.
Key exclusion criteria (10 listed)
- Current manic or psychotic episode.
- Major or minor neurocognitive disorder.
- Neurodevelopmental disorder, including attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD).
- Any medical or psychiatric condition requiring immediate hospitalization at the time of enrollment. Psychiatry day hospital care does not constitute an exclusion criterion.
- History of a structural lesion of the central nervous system.
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 |
|---|---|---|
| Intermittent theta-burst stimulation (iTBS)A single session of neuronavigated intermittent theta-burst stimulation (iTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, in an intermittent pattern of 2 seconds ON and 8 seconds OFF, for a total of 600 pulses over approximately 190 seconds. | Device | Intermittent Theta-Burst Stimulation (iTBS) |
| Continuous theta-burst stimulation (cTBS)A single session of neuronavigated continuous theta-burst stimulation (cTBS) is delivered using a MagVenture MagPro X100 with MagOption and the appropriate active coil (Cool-B65 or Cool-D-B80) selected according to the individualized target. Stimulation is delivered at 80% of the individual resting motor threshold (RMT) to a personalized prefrontal site defined using lesion network mapping and SimNIBS. Bursts are delivered at 5 Hz, with 3 pulses at 50 Hz per burst, continuously without interruption, for a total of 600 pulses over approximately 40 seconds. | Device | Continuous Theta-Burst Stimulation (cTBS) |
| Sham theta-burst stimulationA single session of sham theta-burst stimulation is delivered using the MagVenture MagPro X100 with MagOption and a shielded sham coil at the individualized prefrontal target. Coil positioning, neuronavigation display, and auditory and somatosensory characteristics are matched as closely as possible to the active conditions. The programmed sham protocol uses 5-Hz bursts with 3 pulses at 50 Hz per burst, an intermittent pattern of 5 seconds ON and 10 seconds OFF, 600 pulses, a session duration of 110 seconds, and an intensity setting of 80% of the individual RMT. | Device | Sham Theta-Burst Stimulation |
Primary outcome
Post-Stimulation Target-to-Network Resting-State fMRI Functional Connectivity
Time frame: Within approximately 30 minutes after each stimulation session at crossover Visits 2, 3, and 4 (Weeks 2, 4, and 6; visits separated by at least 1 week)
Resting-state fMRI functional connectivity between the individualized prefrontal stimulation target and the lesion-defined restrictive-eating network, quantified using the target-to-network connectivity index. The measure is assessed after each iTBS, cTBS, and sham session and compared within participants across the three stimulation conditions.
4 secondary outcomes
GNAT Inhibitory-Control Performance (d-prime) After Stimulation
Time frame: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Body Discrepancy Index After Stimulation
Time frame: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Post-Stimulation Task-Based fMRI BOLD Signal in the Lesion-Defined Network
Time frame: During post-stimulation task-based fMRI at crossover Visits 2, 3, and 4, within approximately 30 minutes after stimulation
Eating Disorder Psychopathology Assessed With the EDE-Q
Time frame: Pre-stimulation at crossover Visits 2, 3, and 4 (approximately Weeks 2, 4, and 6; visits separated by at least 1 week)
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 6 Oct 2026.
- Background: PubMed 35075120Cotovio G, Oliveira-Maia AJ. Functional neuroanatomy of mania. Transl Psychiatry. 2022 Jan 24;12(1):29. doi: 10.1038/s41398-022-01786-4.
- Background: PubMed 41359596Cotovio G, Seybert C, Rodrigues da Silva D, Faro Viana F, Estrela JP, Pereira P, Oliveira-Maia AJ. Conventional Repetitive Transcranial Magnetic Stimulation for Depression: A Step-by-Step Protocol. J Vis Exp. 2025 Nov 21;(225). doi: 10.3791/68891.
- Background: PubMed 37508962Cotovio G, Ventura F, Rodrigues da Silva D, Pereira P, Oliveira-Maia AJ. Regulatory Clearance and Approval of Therapeutic Protocols of Transcranial Magnetic Stimulation for Psychiatric Disorders. Brain Sci. 2023 Jul 5;13(7):1029. doi: 10.3390/brainsci13071029.
- Background: PubMed 21727255Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
- Background: PubMed 38863340Soeby M, Gribsholt SB, Clausen L, Richelsen B. Overall and cause-specific mortality in anorexia nervosa; impact of psychiatric comorbidity and sex in a 40-year follow-up study. Int J Eat Disord. 2024 Sep;57(9):1842-1853. doi: 10.1002/eat.24223. Epub 2024 Jun 12.
- Background: PubMed 32359125Wonderlich SA, Bulik CM, Schmidt U, Steiger H, Hoek HW. Severe and enduring anorexia nervosa: Update and observations about the current clinical reality. Int J Eat Disord. 2020 Aug;53(8):1303-1312. doi: 10.1002/eat.23283. Epub 2020 May 2.
- Background: PubMed 26514083Zipfel S, Giel KE, Bulik CM, Hay P, Schmidt U. Anorexia nervosa: aetiology, assessment, and treatment. Lancet Psychiatry. 2015 Dec;2(12):1099-111. doi: 10.1016/S2215-0366(15)00356-9. Epub 2015 Oct 27.
- Background: PubMed 27189821Treasure J, Zipfel S, Micali N, Wade T, Stice E, Claudino A, Schmidt U, Frank GK, Bulik CM, Wentz E. Anorexia nervosa. Nat Rev Dis Primers. 2015 Nov 26;1:15074. doi: 10.1038/nrdp.2015.74.
- Background: PubMed 37917374Lakritz C, Iceta S, Duriez P, Makdassi M, Masetti V, Davidenko O, Lafraire J. Measuring implicit associations between food and body stimuli in anorexia nervosa: a Go/No-Go Association Task. Eat Weight Disord. 2023 Nov 2;28(1):93. doi: 10.1007/s40519-023-01621-9.
- Background: PubMed 38539589Wu K, Lo YT, Cavaleri J, Bergosh M, Ipe J, Briggs RG, Jann KB, Murray SB, Mason XL, Liu CY, Lee DJ. Neuromodulation of Eating Disorders: A Review of Underlying Neural Network Activity and Neuromodulatory Treatments. Brain Sci. 2024 Feb 22;14(3):200. doi: 10.3390/brainsci14030200.
- Background: PubMed 39740315Longo P, Bevione F, Lacidogna MC, Lavalle R, Abbate Daga G, Preti A. Neuromodulatory techniques in eating disorders: From electroconvulsive therapy to transcranial magnetic stimulation and beyond: A mixed method systematic meta-review. Psychiatry Res. 2025 Feb;344:116346. doi: 10.1016/j.psychres.2024.116346. Epub 2024 Dec 27.
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- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data (IPD) or associated data dictionaries available to external researchers. Any future data-sharing proposal would be considered on a case-by-case basis and would require appropriate authorization by the Sponsor and Data Protection Officer and compliance with applicable data-protection requirements.
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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.
Gonçalo Cotovio, MD, PhD principal investigator
Champalimaud Foundation
Albino J. Oliveira-Maia, MD, MPH, PhD study director
Champalimaud Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta-burst stimulation (iTBS) and Continuous theta-burst stimulation (cTBS) in people with Anorexia Nervosa, run by Fundacao Champalimaud at 1 site in Portugal.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Oct 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 Portugal. 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 Gonçalo Cotovio, MD, PhD (+351 210 480 200, goncalo.cotovio@neuro.fchampalimaud.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Stimulation Target-to-Network Resting-State fMRI Functional Connectivity (time frame: Within approximately 30 minutes after each stimulation session at crossover Visits 2, 3, and 4 (Weeks 2, 4, and 6; visits separated by at least 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860320, which also lists 20 linked publications.
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 6 Oct 2026.