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

April 5, 2023 updated by: Bambino Gesù Hospital and Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Recruiting
        • Bambino Gesù Hospital and Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AN Active tDCS
Treatment "as usual" plus experimental treatment
Device: 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.

Other Names:
  • Brain Stim
Sham Comparator: AN Sham tDCS
Treatment "as usual" plus placebo treatment
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.
Other Names:
  • Brain Stim Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant changes in the physiological measures specifically the BMI index
Time Frame: 12 months follow up
12 months follow up
Number of participants with abnormal laboratory blood test results.
Time Frame: 12 months follow up
12 months follow up
Significant changes in the endogenous stress response, measured with Cortisol Awakening Response (CAR).
Time Frame: 12 months follow up
12 months follow up
Significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as short intracortical inhibition and facilitation.
Time Frame: 6 weeks
the ratio between MEPs amplitude conditioning stimulus and MEPs amplitude test stimulus alone for each ISI.
6 weeks
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.
Time Frame: 6 weeks
6 weeks
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.
Time Frame: 6 weeks
6 weeks
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.
Time Frame: 6 weeks
6 weeks
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.
Time Frame: 6 weeks
6 weeks
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.
Time Frame: 6 weeks
6 weeks
Significant changes in the total scores of AN symptomatology measures as Eating Attitudes Test (EAT-26)
Time Frame: 12 months follow up
The EAT-26 proposes a cut-off score of 20. Scores of 20 or higher were considered clinically significant.
12 months follow up
Significant changes in the total scores of AN symptomatology measures as Body Uneasiness Test (BUT).
Time Frame: 12 months follow up
The BUT proposes a cut-off score of 1,2. Scores of 1,2 or higher were considered clinically significant.
12 months follow up
Significant changes in the total scores of other psychopathological measures as Child Behavior Checklist (CBCL 6-18).
Time Frame: 12 months follow up
The CBCL 6-18 generates a T-score for each subscale. According to normative data, a T-score above 64 was considered to be significant for the 3 broadband scales, whereas for the syndrome scales, the cut-off for clinical significance was 70.
12 months follow up
Significant changes in the total scores of other psychopathological measures as Children's Depression Inventory (CDI).
Time Frame: 12 months follow up
Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance.
12 months follow up
Significant changes in the total scores of other psychopathological measures as Multidimensional Anxiety Scale for Children (MASC).
Time Frame: 12 months follow up
Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance.
12 months follow up
Significant changes in Ineffectiveness (IC) of the EDI-3.
Time Frame: 12 months follow up
Evaluation of the change in Ineffectiveness, with maximum possible score of 48, where higher scores indicate higher Ineffectiveness.
12 months follow up
Significant changes in Interpersonal Problems (IPC) of the EDI-3.
Time Frame: 12 months follow up
Evaluation of the change in Interpersonal Problems, with maximum possible score of 52, where higher scores indicate higher Interpersonal Problems.
12 months follow up
Significant changes in Affective Problems (APC) of the EDI-3.
Time Frame: 12 months follow up
Evaluation of the change in Affective Problems, with maximum possible score of 62, where higher scores indicate higher Affective Problems.
12 months follow up
Significant changes in Overcontrol (OC) of the EDI-3.
Time Frame: 12 months follow up
Evaluation of the change in Overcontrol, with maximum possible score of 52, where higher scores indicate higher Overcontrol.
12 months follow up
Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3.
Time Frame: 12 months follow up
Evaluation of the change in General Psychological Maladjustment, with maximum possible score of 252, where higher scores indicate higher General Psychological Maladjustment.
12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Investigators

  • Principal Investigator: Floriana Costanzo, Bambino Gesù Hospital and Research Institute
  • Study Chair: Stefano Vicari, Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

January 30, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 763_OPBG_2014_BIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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