Anorexia NervosaNCT07106645
Intermittent Theta Burst Transcranial Magnetic Stimulation of the Right Parietal Lobe in Anorexia Nervosa
A study testing Active iTBS in people with Anorexia Nervosa, run by University of Padova at 1 site in Italy.
Trial summary
Anorexia Nervosa is a psychiatric disorder characterized by high rates of chronicity, significant societal costs, and one of the highest mortality rates among psychiatric illnesses. Despite therapeutic advances, treatment outcomes remain poor, with high relapse rates and full recovery achieved in only 50% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 1 Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 18 years or older; (3) failure of an outpatient treatment cycle lasting at least 3 months
Who cannot join
- Exclusion criteria will be: (1) Presence of significant neurological comorbidities or severe/unstable systemic diseases, (2) Diastolic blood pressure <60 mmHg or heart rate <60 bpm, (3) diagnosis of psychosis or substance abuse disorders, (4) history of hypomanic/manic episodes (5) Current suicidal ideation, (6) known contraindications to TMS (epilepsy, head trauma with loss of consciousness, severe/frequent headaches, cochlear implants, pacemakers, pregnancy, metallic implants, implanted neurostimulators)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valentina Meregalli, PhD contact
Italy1 site
Psychiatric Unit
Padova, Padova, 35122
Enrico Collantoni, enrico.collantoni@unipd.it
About this study
Official title: Transcranial Magnetic Stimulation in Anorexia Nervosa: A Double-Blind Randomized Study on the Efficacy of Intermittent Theta Burst Stimulation of the Right Parietal Lobe
Anorexia Nervosa is a psychiatric disorder characterized by high rates of chronicity, significant societal costs, and one of the highest mortality rates among psychiatric illnesses. Despite therapeutic advances, treatment outcomes remain poor, with high relapse rates and full recovery achieved in only 50% of cases.
Recent cognitive, behavioral, and neuroimaging studies suggest that Anorexia Nervosa may involve dysfunction in a posterior parietal network responsible for multisensory integration. This network plays a pivotal role in bodily self-representation and the modulation of environment-body interactions, and may therefore be directly implicated in two core symptoms of the disorder: distorted body image representation and dietary restriction. Given these insights, Transcranial Magnetic Stimulation (TMS) - an established neuromodulation technique with proven efficacy in various psychiatric disorders - emerges as a promising investigational intervention. The aim of this study is to evaluate the feasibility and therapeutic efficacy of a protocol of intermittent Theta Burst Stimulation (iTBS) targeting the right posterior parietal lobe in patients with Anorexia Nervosa. The active iTBS protocol will be compared to a sham (placebo) stimulation as a control condition.
Read the detailed description
Patients with anorexia nervosa will be recruited from the Eating Disorder Unit of Padova Hospital. Inclusion criteria will be: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 18 years or older; (3) failure of an outpatient treatment cycle lasting at least 3 months. Exclusion criteria will be: (1) Presence of significant neurological comorbidities or severe/unstable systemic diseases, (2) Diastolic blood pressure <60 mmHg or heart rate <60 bpm, (3) diagnosis of psychosis or substance abuse disorders, (4) history of hypomanic/manic episodes (5) Current suicidal ideation, (6) known contraindications to TMS (epilepsy, head trauma with loss of consciousness, severe/frequent headaches, cochlear implants, pacemakers, pregnancy, metallic implants, implanted neurostimulators)
Each patient will be randomly assigned to one of two conditions: active iTBS or sham stimulation
iTBS protocol: Patients in this condition will undergo 20 sessions of iTBS, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Intermittent theta burst stimulation will involve the delivery of triplets of pulses at 50 Hz, repeated at 5 Hz, at 100% of the individual motor threshold.
Sham Stimulation: Patients in this condition will undergo the same protocol (20 sessions of TMS), with the only difference being the use of a sham coil, which produces the same sound as the real coil without generating a magnetic field
Patients in both conditions will complete a baseline assessment (Day 0), an end-of-treatment assessment (Week 4), and a follow-up assessment (4 months after the end of treatment).
All the assessments will include:
Clinical interview with a psychiatrist who is blind to the stimulation condition. During the interview, the clinician will also record the patients' weight and height to calculate Body Mass Index (BMI).
Depression Anxiety Stress Scales - 21 items (DASS-21): a validated 21-item scale for assessing depression, anxiety, and stress.
Eating Disorders Inventory (EDI-I): a validated 64-item scale for assessing eating disorder psychopathology.
Body Attitude Questionnaire: a validated questionnaire on body dissatisfaction and body perception.
Wisconsin Card Sorting Task (WCST): assessment of set-shifting abilities.
Rey-Osterrieth Complex Figure Test: assessment of central coherence.
- Conditions
- Anorexia Nervosa
- Being tested
- Active iTBS, Sham stimulation
- Keywords
- psychiatry, eating disorders, neurostimulation, TMS, Transcranial Magnetic Stimulation, Anorexia Nervosa
- 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.
Active iTBSDevice
Patients in this condition will undergo 20 sessions of iTBS, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Intermittent theta burst stimulation will involve the delivery of triplets of pulses at 50 Hz, repeated at 5 Hz, at 100% of the individual motor threshold.
Sham stimulationDevice
Patients in this condition will undergo 20 sessions of sham stimulation, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Sham stimulation will be identical to active stimulation, with the only difference being the use of a sham coil, which produces the same sound as the real coil without generating a magnetic field
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Experimental | Patients in this condition will undergo 20 sessions of iTBS over the right posterior parietal lobe, one per day for 20 consecutive working days (4 weeks) Receives: Device: Active iTBS |
| sham stimulation | Active comparator | Patients in this condition will undergo 20 sessions of sham stimulation over the right posterior parietal lobe, one per day for 20 consecutive working days (4 weeks) Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Body Mass Index (BMI)
BMI will be calculated from patients' height and weight using the formula: weight (kg) divided by height (m) squared.
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Secondary outcomes (5)
Change from baseline in depression, anxiety and stress
The DASS-21 is a validated self-report instrument consisting of three subscales assessing symptoms of depression, anxiety, and stress. The score of each subscale can range from 0 to 42, with higher scores representing higher levels of psychopathology.
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in eating disorder psychopathology
The EDI-I is a 64-item self-report scale for the assessment of eating disorder psychopathology. The scale comprises 8 subscales (drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears). Total score ranges from 64 to 384 and greater scores indicate greater psychopathology
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in body dissatisfaction and perception
The Body Attitude Questionnaire is a 26 item self-report scale for the assessment of body dissatisfaction and perception. The questionnaire comprises 3 subscales (body satisfaction, body concern, body distortion). Total score ranges from 26 to 130 and higher scores indicate greater body dissatisfaction and concern.
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in cognitive flexibility
The Wisconsin Card Sorting Task is a well-validated neuropsychological task for the assessment of cognitive flexibility. As outcome variables, the number of perseverative responses and perseverative errors will be taken into account.
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in central coherence
The Rey-Osterrieth complex figure is a well-validated neuropsychological test for the assessment of visuospatial functioning and memory. As outcome variables, the indexes of central coherence in both the copy and memory phase will be taken into account.
Measured: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be randomly assigned to one of two conditions: (1) active iTBS; (2) sham stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Responsible party
- Sponsor
- Investigators
- Enrico Collantoni, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106645
- Sponsor's protocol ID
- 6168/EST/25
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Collantoni E, Gentili S, Menardi A, Vallesi A, Librizzi G, Tenconi E, Serino A, Risso G, Olivo D, Sambataro F, Favaro A, Meregalli V. Connectivity-Guided Individualized iTBS of the Posterior Parietal Cortex in Enduring Anorexia Nervosa: Network-Level Target Engagement and Multimodal Response in a Single Case. CNS Neurosci Ther. 2026 Oct;32(10):e71206. doi: 10.1002/cns.71206.
PubMed 42857906Meregalli V, Gentili S, Menardi A, Vallesi A, Olivo D, Manara R, Serino A, Risso G, Sambataro F, Favaro A, Collantoni E. Individualized targeting of the posterior parietal cortex with intermittent theta burst stimulation in anorexia nervosa: a randomized, double-blind, sham-controlled protocol. Front Neurosci. 2026 Jan 21;19:1733280. doi: 10.3389/fnins.2025.1733280. eCollection 2025.
PubMed 41648851
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Anorexia Nervosa: A Double-Blind Randomized Study on the Efficacy of Intermittent Theta Burst Stimulation of the Right Parietal Lobe
- ClinicalTrials.gov ID
- NCT07106645
- Acronym / sponsor ID
- 6168/EST/25
- Conditions
- Anorexia Nervosa
- Keywords
- psychiatry, eating disorders, neurostimulation, TMS, Transcranial Magnetic Stimulation, Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Padova
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
Anorexia Nervosa is a psychiatric disorder characterized by high rates of chronicity, significant societal costs, and one of the highest mortality rates among psychiatric illnesses. Despite therapeutic advances, treatment outcomes remain poor, with high relapse rates and full recovery achieved in only 50% of cases.
Recent cognitive, behavioral, and neuroimaging studies suggest that Anorexia Nervosa may involve dysfunction in a posterior parietal network responsible for multisensory integration. This network plays a pivotal role in bodily self-representation and the modulation of environment-body interactions, and may therefore be directly implicated in two core symptoms of the disorder: distorted body image representation and dietary restriction. Given these insights, Transcranial Magnetic Stimulation (TMS) - an established neuromodulation technique with proven efficacy in various psychiatric disorders - emerges as a promising investigational intervention. The aim of this study is to evaluate the feasibility and therapeutic efficacy of a protocol of intermittent Theta Burst Stimulation (iTBS) targeting the right posterior parietal lobe in patients with Anorexia Nervosa. The active iTBS protocol will be compared to a sham (placebo) stimulation as a control condition.
Detailed description
Patients with anorexia nervosa will be recruited from the Eating Disorder Unit of Padova Hospital. Inclusion criteria will be: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 18 years or older; (3) failure of an outpatient treatment cycle lasting at least 3 months. Exclusion criteria will be: (1) Presence of significant neurological comorbidities or severe/unstable systemic diseases, (2) Diastolic blood pressure <60 mmHg or heart rate <60 bpm, (3) diagnosis of psychosis or substance abuse disorders, (4) history of hypomanic/manic episodes (5) Current suicidal ideation, (6) known contraindications to TMS (epilepsy, head trauma with loss of consciousness, severe/frequent headaches, cochlear implants, pacemakers, pregnancy, metallic implants, implanted neurostimulators)
Each patient will be randomly assigned to one of two conditions: active iTBS or sham stimulation
iTBS protocol: Patients in this condition will undergo 20 sessions of iTBS, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Intermittent theta burst stimulation will involve the delivery of triplets of pulses at 50 Hz, repeated at 5 Hz, at 100% of the individual motor threshold.
Sham Stimulation: Patients in this condition will undergo the same protocol (20 sessions of TMS), with the only difference being the use of a sham coil, which produces the same sound as the real coil without generating a magnetic field
Patients in both conditions will complete a baseline assessment (Day 0), an end-of-treatment assessment (Week 4), and a follow-up assessment (4 months after the end of treatment).
All the assessments will include:
Clinical interview with a psychiatrist who is blind to the stimulation condition. During the interview, the clinician will also record the patients' weight and height to calculate Body Mass Index (BMI).
Depression Anxiety Stress Scales - 21 items (DASS-21): a validated 21-item scale for assessing depression, anxiety, and stress.
Eating Disorders Inventory (EDI-I): a validated 64-item scale for assessing eating disorder psychopathology.
Body Attitude Questionnaire: a validated questionnaire on body dissatisfaction and body perception.
Wisconsin Card Sorting Task (WCST): assessment of set-shifting abilities.
Rey-Osterrieth Complex Figure Test: assessment of central coherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will be randomly assigned to one of two conditions: (1) active iTBS; (2) sham stimulation
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Experimental | Device: Active iTBSPatients in this condition will undergo 20 sessions of iTBS over the right posterior parietal lobe, one per day for 20 consecutive working days (4 weeks) |
| sham stimulation | Active comparator | Device: Sham stimulationPatients in this condition will undergo 20 sessions of sham stimulation over the right posterior parietal lobe, one per day for 20 consecutive working days (4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will be: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 18 years or older; (3) failure of an outpatient treatment cycle lasting at least 3 months
Key exclusion criteria (1 listed)
- Exclusion criteria will be: (1) Presence of significant neurological comorbidities or severe/unstable systemic diseases, (2) Diastolic blood pressure <60 mmHg or heart rate <60 bpm, (3) diagnosis of psychosis or substance abuse disorders, (4) history of hypomanic/manic episodes (5) Current suicidal ideation, (6) known contraindications to TMS (epilepsy, head trauma with loss of consciousness, severe/frequent headaches, cochlear implants, pacemakers, pregnancy, metallic implants, implanted neurostimulators)
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 |
|---|---|---|
| Active iTBSPatients in this condition will undergo 20 sessions of iTBS, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Intermittent theta burst stimulation will involve the delivery of triplets of pulses at 50 Hz, repeated at 5 Hz, at 100% of the individual motor threshold. | Device | active iTBS |
| Sham stimulationPatients in this condition will undergo 20 sessions of sham stimulation, one per day for 20 consecutive working days (4 weeks). Each visit will last approximately 20 minutes, including preparation, 3 minutes of stimulation, and debriefing. The coil position will be identified using a neuronavigation system based on each participant's MRI. Sham stimulation will be identical to active stimulation, with the only difference being the use of a sham coil, which produces the same sound as the real coil without generating a magnetic field | Device | sham stimulation |
Primary outcome
Change from baseline in Body Mass Index (BMI)
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
BMI will be calculated from patients' height and weight using the formula: weight (kg) divided by height (m) squared.
5 secondary outcomes
Change from baseline in depression, anxiety and stress
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in eating disorder psychopathology
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in body dissatisfaction and perception
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in cognitive flexibility
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
Change from baseline in central coherence
Time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)
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 Aug 2025.
- Derived from this study: PubMed 42857906Collantoni E, Gentili S, Menardi A, Vallesi A, Librizzi G, Tenconi E, Serino A, Risso G, Olivo D, Sambataro F, Favaro A, Meregalli V. Connectivity-Guided Individualized iTBS of the Posterior Parietal Cortex in Enduring Anorexia Nervosa: Network-Level Target Engagement and Multimodal Response in a Single Case. CNS Neurosci Ther. 2026 Oct;32(10):e71206. doi: 10.1002/cns.71206.
- Derived from this study: PubMed 41648851Meregalli V, Gentili S, Menardi A, Vallesi A, Olivo D, Manara R, Serino A, Risso G, Sambataro F, Favaro A, Collantoni E. Individualized targeting of the posterior parietal cortex with intermittent theta burst stimulation in anorexia nervosa: a randomized, double-blind, sham-controlled protocol. Front Neurosci. 2026 Jan 21;19:1733280. doi: 10.3389/fnins.2025.1733280. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Valentina Meregalli, PhD contact
Enrico Collantoni, MD, PhD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active iTBS in people with Anorexia Nervosa, run by University of Padova at 1 site in Italy.
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 1 inclusion and 1 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 Aug 2025. 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 Italy. 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. 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 Enrico Collantoni, MD, PhD (+390498218175, enrico.collantoni@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Body Mass Index (BMI) (time frame: Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)). 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 NCT07106645, which also lists 2 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 Aug 2025.