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

NCT ID: NCT05674266

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2025-01-30

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.

Conditions

Anorexia in Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AN Active tDCS

Treatment "as usual" plus experimental treatment

Group Type: EXPERIMENTAL

AN Active tDCS

Intervention Type: DEVICE

The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.

tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.

The anode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement.

Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.

AN Sham tDCS

Treatment "as usual" plus placebo treatment

Group Type: SHAM_COMPARATOR

AN Sham tDCS

Intervention Type: DEVICE

The same electrode placement will be used as in the stimulation conditions (left anodal/right cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.

Interventions

AN Active tDCS

The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.

tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.

The anode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement.

Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.

Intervention Type: DEVICE

AN Sham tDCS

The same electrode placement will be used as in the stimulation conditions (left anodal/right cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.

Intervention Type: DEVICE

Other Intervention Names

Brain Stim; Brain Stim Sham

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Floriana Costanzo

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Hospital and Research Institute

Stefano Vicari

Role: STUDY_CHAIR

Bambino Gesù Hospital and Research Institute

Locations

Bambino Gesù Hospital and Research Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Floriana Costanzo

Role: CONTACT

floriana.costanzo@opbg.net

0668597091

Valeria Zanna

Role: CONTACT

valeira.zanna@opbg.net

Facility Contacts

Chiara Mennini

Role: primary

chiara.mennini@opbg.net

06-68592572

Rita Alparone

Role: backup

rita.alparone@opbg.net

06-68593580

References

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.

Reference Type: BACKGROUND

PMID: 21320389 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30083095 (View on PubMed)

Ursumando L, Ponzo V, Monteleone AM, Menghini D, Fuca E, Lazzaro G, Esposito R, Picazio S, Koch G, Zanna V, Vicari S, Costanzo F. The efficacy of non-invasive brain stimulation in the treatment of children and adolescents with Anorexia Nervosa: study protocol of a randomized, double blind, placebo-controlled trial. J Eat Disord. 2023 Aug 2;11(1):127. doi: 10.1186/s40337-023-00852-6.

Reference Type: DERIVED

PMID: 37533058 (View on PubMed)

Other Identifiers

763_OPBG_2014_BIS

Identifier Type: -

Identifier Source: org_study_id