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.
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)
Parallel
Active iTBS
DevicePatients 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
DevicePatients 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
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.
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.
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
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.
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.
feasibility and acceptability of iTBS treatment
percentage of patients who will complete the intervention
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University of Padova
Lead sponsor
Azienda Ospedaliera di Padova
Collaborator
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