New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment

Bambino Gesù Hospital and Research Institute

Status: Enrolling

Conditions: Anorexia in Adolescence

Treatments: Device: AN Active tDCS; Device: AN Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05674266

763_OPBG_2014_BIS

Details and patient eligibility

About

The present randomized, double blind, placebo-controlled trial aims at evaluating the efficacy of a tDCS treatment in improving the clinical outcome of adolescents with AN and investigate brain mechanisms acting in AN.

Full description

The investigators hypothesized that excitatory tDCS over the left PFC and inhibitory tDCS over the right PFC (anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in children and adolescents with AN, reducing their control over eating behaviors and improving the AN psychopathology. Furthermore, the investigators will employ TMS-EEG to directly explore the DLPFC activity of children and adolescent with AN, with specific attention to the differences between hemispheres. Moreover, paired pulse TMS and repetitive TMS protocols will be used to investigate the functional mechanisms within the prefrontal cortex of youth patients with AN. Then, the investigators will assess if potential changes of specific biomarkers, such as those related to the endogenous stress response system functioning, will occur after tDCS treatment and will correlate with clinical improvement.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition - DSM-5 (American Psychiatric Association & American Psychiatric Association, 2013);
• condition of under-weight (BMI <18.5 kg/m2);
• intelligence quotient higher or equal to 85 (IQ ≥ 85);
• ability to give informed consent under parents' surveillance and guidance

Exclusion criteria

• a personal history of neurological/medical/genetic diseases;
• a personal history of epilepsy;
• suicide risk;
• receiving CNS-active drug, other counseling or psychological therapies during the treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

AN Active tDCS

Experimental group

Description:

Treatment "as usual" plus experimental treatment

Treatment:

Device: AN Active tDCS

AN Sham tDCS

Sham Comparator group

Description:

Treatment "as usual" plus placebo treatment

Treatment:

Device: AN Sham tDCS