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Clinical Trials in Italy / NCT07106645
Starting soon Not applicable

Intermittent Theta Burst Transcranial Magnetic Stimulation of the Right Parietal Lobe in Anorexia Nervosa

NCT07106645 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-09-01
Last updated
2025-08-06

Condition(s) studied

Anorexia Nervosa

Investigational drug(s) / intervention(s)

Active iTBSSham stimulation

Active iTBS: 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 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 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.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Psychiatric Unit Padova Padova

More University of Padova trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106645 on ClinicalTrials.gov ↗ ← All trials in Italy