Anorexia in AdolescenceNCT05674266
New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment
A study testing AN Active tDCS in people with Anorexia in Adolescence, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anorexia in Adolescence
- What is being tested?
- AN Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2020to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Valeria Zanna contact
Italy1 site, 1 recruiting
- Recruiting
Bambino Gesù Hospital and Research Institute
Rome, 00165
Chiara Mennini, 06-68592572, chiara.mennini@opbg.net
Rita Alparone, 06-68593580, rita.alparone@opbg.net
About this study
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.
Read the 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
- Being tested
- AN Active tDCS, AN Sham tDCS
- Keywords
- tDCS, EEG, TMS, cortisol, eating disorder, neuromodulation
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN Active tDCSDevice
Also called Brain Stim
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 tDCSDevice
Also called Brain Stim Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| AN Active tDCS | Experimental | Treatment "as usual" plus experimental treatment Receives: Device: AN Active tDCS |
| AN Sham tDCS | Sham comparator | Treatment "as usual" plus placebo treatment Receives: Device: AN Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (19)
Significant changes in Ineffectiveness (IC) of the EDI-3.
Evaluation of the change in Ineffectiveness, with maximum possible score of 48, where higher scores indicate higher Ineffectiveness.
Measured: 12 months follow up
Significant changes in Interpersonal Problems (IPC) of the EDI-3.
Evaluation of the change in Interpersonal Problems, with maximum possible score of 52, where higher scores indicate higher Interpersonal Problems.
Measured: 12 months follow up
Significant changes in Affective Problems (APC) of the EDI-3.
Evaluation of the change in Affective Problems, with maximum possible score of 62, where higher scores indicate higher Affective Problems.
Measured: 12 months follow up
Significant changes in Overcontrol (OC) of the EDI-3.
Evaluation of the change in Overcontrol, with maximum possible score of 52, where higher scores indicate higher Overcontrol.
Measured: 12 months follow up
Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3.
Evaluation of the change in General Psychological Maladjustment, with maximum possible score of 252, where higher scores indicate higher General Psychological Maladjustment.
Measured: 12 months follow up
Significant changes in the total scores of AN symptomatology measures as Eating Attitudes Test (EAT-26)
The EAT-26 proposes a cut-off score of 20. Scores of 20 or higher were considered clinically significant.
Measured: 12 months follow up
Significant changes in the total scores of AN symptomatology measures as Body Uneasiness Test (BUT).
The BUT proposes a cut-off score of 1,2. Scores of 1,2 or higher were considered clinically significant.
Measured: 12 months follow up
Significant changes in the total scores of other psychopathological measures as Child Behavior Checklist (CBCL 6-18).
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.
Measured: 12 months follow up
Significant changes in the total scores of other psychopathological measures as Children's Depression Inventory (CDI).
Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance.
Measured: 12 months follow up
Significant changes in the total scores of other psychopathological measures as Multidimensional Anxiety Scale for Children (MASC).
Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance.
Measured: 12 months follow up
Significant changes in the physiological measures specifically the BMI index
Measured: 12 months follow up
Number of participants with abnormal laboratory blood test results.
Measured: 12 months follow up
Significant changes in the endogenous stress response, measured with Cortisol Awakening Response (CAR).
Measured: 12 months follow up
Significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as short intracortical inhibition and facilitation.
the ratio between MEPs amplitude conditioning stimulus and MEPs amplitude test stimulus alone for each ISI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start30 Jun 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anorexia in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Floriana Costanzo, Principal investigator, Bambino Gesù Hospital and Research InstituteStefano Vicari, Study chair, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674266
- Sponsor's protocol ID
- 763_OPBG_2014_BIS
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21320389Costanzo 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.
PubMed 30083095Battisti A, Lazzaro G, Ursumando L, D'Aiello B, Zanna V, Costanzo F, Vicari S, Menghini D. Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders. Sci Rep. 2025 Feb 7;15(1):4560. doi: 10.1038/s41598-025-88256-1.
PubMed 39915614Ursumando 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.
PubMed 37533058
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment
- ClinicalTrials.gov ID
- NCT05674266
- Acronym / sponsor ID
- 763_OPBG_2014_BIS
- Conditions
- Anorexia in Adolescence
- Keywords
- tDCS, EEG, TMS, cortisol, eating disorder, neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AN Active tDCS | Experimental | Device: AN Active tDCSTreatment "as usual" plus experimental treatment |
| AN Sham tDCS | Sham comparator | Device: AN Sham tDCSTreatment "as usual" plus placebo treatment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN Active tDCSAlso: Brain StimThe 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. | Device | AN Active tDCS |
| AN Sham tDCSAlso: Brain Stim ShamThe 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. | Device | AN Sham tDCS |
Primary outcome
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.
19 secondary outcomes
Significant changes in Ineffectiveness (IC) of the EDI-3.
Time frame: 12 months follow up
Significant changes in Interpersonal Problems (IPC) of the EDI-3.
Time frame: 12 months follow up
Significant changes in Affective Problems (APC) of the EDI-3.
Time frame: 12 months follow up
Significant changes in Overcontrol (OC) of the EDI-3.
Time frame: 12 months follow up
Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3.
Time frame: 12 months follow up
Significant changes in the total scores of AN symptomatology measures as Eating Attitudes Test (EAT-26)
Time frame: 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
Significant changes in the total scores of other psychopathological measures as Child Behavior Checklist (CBCL 6-18).
Time frame: 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
Significant changes in the total scores of other psychopathological measures as Multidimensional Anxiety Scale for Children (MASC).
Time frame: 12 months follow up
Significant changes in the physiological measures specifically the BMI index
Time frame: 12 months follow up
Number of participants with abnormal laboratory blood test results.
Time frame: 12 months follow up
Significant changes in the endogenous stress response, measured with Cortisol Awakening Response (CAR).
Time frame: 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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 21320389Brunoni 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.
- Results publication: PubMed 30083095Costanzo 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.
- Derived from this study: PubMed 39915614Battisti A, Lazzaro G, Ursumando L, D'Aiello B, Zanna V, Costanzo F, Vicari S, Menghini D. Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders. Sci Rep. 2025 Feb 7;15(1):4560. doi: 10.1038/s41598-025-88256-1.
- Derived from this study: PubMed 37533058Ursumando 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Zanna contact
Floriana Costanzo principal investigator
Bambino Gesù Hospital and Research Institute
Stefano Vicari study chair
Bambino Gesù Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN Active tDCS in people with Anorexia in Adolescence, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floriana Costanzo (0668597091, floriana.costanzo@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674266, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.