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

NCT05674266 | Unknown

• 1 other identifier: 763_OPBG_2014_BIS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia in Adolescence

Keywords

tDCS; EEG; TMS; cortisol; eating disorder; neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  EDI-3 comprises 91-item that give a measure of the basic characteristics of the ED through six composite scores \[Eating Disorder Risk (EDRC) (range 0-100), Ineffectiveness (IC) (range 0-48), Interpersonal Problems (IPC) (range 0-52), Affective Problems (APC) (range 0-62), Overcontrol (OC) (range 0-52), and General Psychological Maladjustment (GPMC) (range 0-252)\]. Higher scores indicates more severe problems.

  6 weeks

Secondary Outcomes (19)

• Significant changes in Ineffectiveness (IC) of the EDI-3.

  12 months follow up

• Significant changes in Interpersonal Problems (IPC) of the EDI-3.

  12 months follow up

• Significant changes in Affective Problems (APC) of the EDI-3.

  12 months follow up

• Significant changes in Overcontrol (OC) of the EDI-3.

  12 months follow up

• Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3.

  12 months follow up

Study Arms (2)

AN Active tDCS

EXPERIMENTAL

Treatment "as usual" plus experimental treatment

Device: AN Active tDCS

AN Sham tDCS

SHAM COMPARATOR

Treatment "as usual" plus placebo treatment

Device: AN Sham tDCS

Interventions

AN Active tDCS 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.

Also known as: Brain Stim

AN Active tDCS

AN Sham tDCS 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.

Also known as: Brain Stim Sham

AN Sham tDCS

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Rome, 00165, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 21320389 BACKGROUND

• 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.

  PMID: 30083095 RESULT

• 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.

  PMID: 37533058 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Floriana Costanzo

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Stefano Vicari

  Bambino Gesù Hospital and Research Institute

  STUDY CHAIR

Central Study Contacts

Floriana Costanzo

CONTACT

0668597091; floriana.costanzo@opbg.net

Valeria Zanna

CONTACT

valeira.zanna@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 6, 2023
• Study Start: June 30, 2020
• Primary Completion: June 30, 2023
• Study Completion: January 30, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IT (1)