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

NCT07106645 | Not Yet Recruiting

• 1 other identifier: 6168/EST/25
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

psychiatry; eating disorders; neurostimulation; TMS; Transcranial Magnetic Stimulation; Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)

• Change from baseline in eating disorder psychopathology

  Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)

• Change from baseline in body dissatisfaction and perception

  Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)

• Change from baseline in cognitive flexibility

  Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)

• Change from baseline in central coherence

  Day 0 (baseline), Week 4 (end of treatment), Week 20 (4-month follow-up)

Other Outcomes (1)

• feasibility and acceptability of iTBS treatment

  4 weeks

Study Arms (2)

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)

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)

Device: Sham stimulation

Interventions

Active iTBS DEVICE

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.

active iTBS

Sham stimulation DEVICE

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

sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Padova: lead
• Azienda Ospedaliera di Padova: collaborator

Study Sites (1)

Psychiatric Unit

Padua, Padova, 35122, Italy

Location

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Collantoni, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Collantoni, MD, PhD

CONTACT

+390498218175; enrico.collantoni@unipd.it

Valentina Meregalli, PhD

CONTACT

valentina.meregalli@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patients and experimenters will be blind to the condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be randomly assigned to one of two conditions: (1) active iTBS; (2) sham stimulation

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

IT (1)