Clinical trial NCT05674266: New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment
Official title: New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia in Adolescence
Keywords: tDCS
EEG
TMS
cortisol
eating disorder
neuromodulation
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary end-point of the study is the variance on eating psychopathology at T1, assessed as changes in Eating Disorder Risk score (EDRC) of the Eating Disorder Inventory (EDI-3). Significant changes in Ineffectiveness (IC) of the EDI-3.
timeFrame: 6 weeks
Secondary outcomes:
measure: Significant changes in Ineffectiveness (IC) of the EDI-3.
timeFrame: 12 months follow up
measure: Significant changes in Interpersonal Problems (IPC) of the EDI-3.
timeFrame: 12 months follow up
measure: Significant changes in Affective Problems (APC) of the EDI-3.
timeFrame: 12 months follow up
measure: Significant changes in Overcontrol (OC) of the EDI-3.
timeFrame: 12 months follow up
measure: Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3.
timeFrame: 12 months follow up
measure: Significant changes in the total scores of AN symptomatology measures as Eating Attitudes Test (EAT-26)
timeFrame: 12 months follow up
measure: Significant changes in the total scores of AN symptomatology measures as Body Uneasiness Test (BUT).
timeFrame: 12 months follow up
measure: Significant changes in the total scores of other psychopathological measures as Child Behavior Checklist (CBCL 6-18).
timeFrame: 12 months follow up
measure: Significant changes in the total scores of other psychopathological measures as Children's Depression Inventory (CDI).
timeFrame: 12 months follow up
measure: Significant changes in the total scores of other psychopathological measures as Multidimensional Anxiety Scale for Children (MASC).
timeFrame: 12 months follow up
measure: Significant changes in the physiological measures specifically the BMI index
timeFrame: 12 months follow up
measure: Number of participants with abnormal laboratory blood test results.
timeFrame: 12 months follow up
measure: Significant changes in the endogenous stress response, measured with Cortisol Awakening Response (CAR).
timeFrame: 12 months follow up
measure: Significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as short intracortical inhibition and facilitation.
timeFrame: 6 weeks
measure: Significant changes in sensory-motor integration using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus (electrical stimulation) and MEP amplitude test stimulus alone for each ISI.
timeFrame: 6 weeks
measure: Significant changes in cortical oscillatory patterns (synchronization and desynchronization) in theta, alpha and beta frequencies (Hz) over motor and premotor cortex, using TMS-EEG co-registration.
timeFrame: 6 weeks
measure: Significant changes in cortical connectivity using TMS-EEG co-registration combined to report the analysis of the waveform, latency and cortical distribution of TMS-evoked potentials (TEPs) in micronV.
timeFrame: 6 weeks
measure: Significant changes in cortical reactivity in terms of TMS-evoked potentials (TEPs) amplitude for time domain (micronV) and frequency bands for spatial domain (Hz), using TMS-EEG co-registration.
timeFrame: 6 weeks
measure: Significant changes in Cortical Plasticity evoked by repetitive TMS in terms of different MEP amplitude (mV) recorded at different time-points after repetitive TMS perturbations.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital and Research Institute
Study officials:
affiliation: Bambino Gesù Hospital and Research Institute
name: Floriana Costanzo
role: PRINCIPAL_INVESTIGATOR
affiliation: Bambino Gesù Hospital and Research Institute
name: Stefano Vicari
role: STUDY_CHAIR
References:
citation: Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
citation: Costanzo F, Menghini D, Maritato A, Castiglioni MC, Mereu A, Varuzza C, Zanna V, Vicari S. New Treatment Perspectives in Adolescents With Anorexia Nervosa: The Efficacy of Non-invasive Brain-Directed Treatment. Front Behav Neurosci. 2018 Jul 20;12:133. doi: 10.3389/fnbeh.2018.00133. eCollection 2018.