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Circuit-Guided Neuromodulation for Anorexia Nervosa
Sponsor: Fundacao Champalimaud
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. 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.
Official title: Re-tuning Restrictive Eating Circuits: From Lesion Network Mapping to Personalized Neuromodulation Targets
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09
Completion Date
2027-12
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Sham theta-burst stimulation
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.
Locations (1)
Champalimaud Foundation
Lisbon, Lisbon District, Portugal