Eating DisordersNCT02382497
New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment
A study testing AN Active tDCS and BED Active tDCS in people with Eating Disorders and Binge Eating Disorder, run by Mariella Enoc at 1 site in Italy.
Trial summary
The present study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Eating Disorders, Binge Eating Disorder, Anorexia Nervosa
- What is being tested?
- AN Active tDCS and BED Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to Jul 2023
- 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
- Under-weight (BMI less than 5th percentile)1 with Clinical diagnosis of AN as described in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Over-weight/Obesity (OW/OB) (BMI above the 85th percentile)1 with diagnosis of BED, or with food craving behaviors
- Ability to give informed consent under parents' surveillance and guidance
Who cannot join
- Having a comorbidity with an important medical condition;
- Having neurological diseases
- Having Epilepsy o family history of epilepsy
- Pregnant or planning to become pregnant;
- Suicide risk;
- Receiving counseling or psychological therapies during the study;
- Receiving a treatment for an eating disorder in the previous three months before the baseline screening visit.
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 study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors.
Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.
Read the detailed description
The study design is randomized stratified, double blind, add-on, placebo-controlled.
A group of children and adolescents with AN will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).
Similarly, a group of children and adolescents with Over-weight/Obesity (OW/OB) and BED will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).
In this project, the investigators will work to understand whether a brain-based treatment, with the use of tDCS, can improve the outcome of patients with eating disorders.
The investigators will test whether tDCS treatment produces improvements in under-eating and over-eating diseases, such us AN and OW/OB with BED and food craving.
Our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ED.
- Conditions
- Eating Disorders, Binge Eating Disorder, Anorexia Nervosa
- Being tested
- AN Active tDCS, AN Sham tDCS, BED Active tDCS, BED Sham tDCS
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Anorexia Nervosa
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.
BED 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.
For the OW/OB with diagnosis of BE, or food craving, the anode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the left PFC, F3 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.
BED Sham tDCSDevice
Also called Brain Stim
The same electrode placement will be used as in the stimulation conditions (right anodal/left 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 |
| BED Active tDCS | Experimental | Treatment "as usual" plus experimental treatment Receives: Device: BED Active tDCS |
| BED Sham tDCS | Sham comparator | Treatment "as usual" plus placebo treatment Receives: Device: BED 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 mean change in the Overcontrol composite score of Eating Disorder Inventory - Three (EDI-3) questionnaire, using an approach based on the magnitudes of change.
the mean change in the Overcontrol composite score of the EDI-3 questionnaire gives a measure of the basic characteristics of the eating disorders and is a prognostic measure of outcome of eating disorders. Indeed, patterns of treatment response revealed significantly changes in terms of reduced eating disorder symptoms and fewer psychological problems.
Measured: 6 weeks
Secondary outcomes (16)
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) questionnaire
Measured: 6 weeks
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the BINGE EATING SCALE (BES) questionnaire
Measured: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of executive control and reward sensitivity by the 'Bechara Iowa Gambling' Task
Measured: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of the ability to stop by THE STOP-SIGNAL REACTION-TIME (SSRT) task.
Measured: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of visual attention and task switching by the TRAIL MAKING TEST
Measured: 6 weeks
The proportion of patients in the two arms with normalization of different physiological measures specifically the BMI index
Measured: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of bloody pressure
Measured: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of cardiac frequency
Measured: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of body composition
Measured: 12 months follow up
In the AN group, significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus and MEPs amplitude test stimulus alone for each ISI.
Measured: 6 weeks
In the AN group, 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
In the AN group, 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
In the AN group, normalization of endogenous stress response, measured with CAR.
Measured: 6 months follow up
In the AN group, significant changes in cortical connectivity, through the analysis of the waveform, latency and cortical distribution of TMS-evoked potentials (TEPs) in micronV, using TMS-EEG co-registration.
Measured: 6 weeks
In the AN group, 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
In the AN group, 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 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariella Enoc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariella Enoc, Bambino Gesù Hospital and Research Institute
- Investigators
- Stefano Vicari, Study chair, Bambino Gesù Hospital and Research InstituteFloriana Costanzo, Principal investigator, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382497
- Sponsor's protocol ID
- 763_OPBG_2014
- Status last verified
- Nov 2021
- First submitted
- 27 Feb 2015
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 30083095
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment
- ClinicalTrials.gov ID
- NCT02382497
- Acronym / sponsor ID
- 763_OPBG_2014
- Conditions
- Eating Disorders, Binge Eating Disorder, Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mariella EnocUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- 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 study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors.
Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.
Detailed description
The study design is randomized stratified, double blind, add-on, placebo-controlled.
A group of children and adolescents with AN will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).
Similarly, a group of children and adolescents with Over-weight/Obesity (OW/OB) and BED will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).
In this project, the investigators will work to understand whether a brain-based treatment, with the use of tDCS, can improve the outcome of patients with eating disorders.
The investigators will test whether tDCS treatment produces improvements in under-eating and over-eating diseases, such us AN and OW/OB with BED and food craving.
Our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| 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 |
| BED Active tDCS | Experimental | Device: BED Active tDCSTreatment "as usual" plus experimental treatment |
| BED Sham tDCS | Sham comparator | Device: BED 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 (3 listed)
- Under-weight (BMI less than 5th percentile)1 with Clinical diagnosis of AN as described in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Over-weight/Obesity (OW/OB) (BMI above the 85th percentile)1 with diagnosis of BED, or with food craving behaviors
- Ability to give informed consent under parents' surveillance and guidance
Key exclusion criteria (7 listed)
- Having a comorbidity with an important medical condition;
- Having neurological diseases
- Having Epilepsy o family history of epilepsy
- Pregnant or planning to become pregnant;
- Suicide risk;
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 |
| BED 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. For the OW/OB with diagnosis of BE, or food craving, the anode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the left PFC, F3 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 | BED Active tDCS |
| BED Sham tDCSAlso: Brain StimThe same electrode placement will be used as in the stimulation conditions (right anodal/left 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 | BED Sham tDCS |
Primary outcome
The primary end-point of the study is the mean change in the Overcontrol composite score of Eating Disorder Inventory - Three (EDI-3) questionnaire, using an approach based on the magnitudes of change.
Time frame: 6 weeks
the mean change in the Overcontrol composite score of the EDI-3 questionnaire gives a measure of the basic characteristics of the eating disorders and is a prognostic measure of outcome of eating disorders. Indeed, patterns of treatment response revealed significantly changes in terms of reduced eating disorder symptoms and fewer psychological problems.
16 secondary outcomes
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) questionnaire
Time frame: 6 weeks
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the BINGE EATING SCALE (BES) questionnaire
Time frame: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of executive control and reward sensitivity by the 'Bechara Iowa Gambling' Task
Time frame: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of the ability to stop by THE STOP-SIGNAL REACTION-TIME (SSRT) task.
Time frame: 6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of visual attention and task switching by the TRAIL MAKING TEST
Time frame: 6 weeks
The proportion of patients in the two arms with normalization of different physiological measures specifically the BMI index
Time frame: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of bloody pressure
Time frame: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of cardiac frequency
Time frame: 12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of body composition
Time frame: 12 months follow up
In the AN group, significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus and MEPs amplitude test stimulus alone for each ISI.
Time frame: 6 weeks
In the AN group, 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
In the AN group, 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
In the AN group, normalization of endogenous stress response, measured with CAR.
Time frame: 6 months follow up
In the AN group, significant changes in cortical connectivity, through the analysis of the waveform, latency and cortical distribution of TMS-evoked potentials (TEPs) in micronV, using TMS-EEG co-registration.
Time frame: 6 weeks
In the AN group, 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
In the AN group, 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 19 Nov 2021.
- 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.
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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
Stefano Vicari study chair
Bambino Gesù Hospital and Research Institute
Floriana Costanzo principal investigator
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 and BED Active tDCS in people with Eating Disorders and Binge Eating Disorder, run by Mariella Enoc 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 3 inclusion and 7 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 19 Nov 2021. 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 mean change in the Overcontrol composite score of Eating Disorder Inventory - Three (EDI-3) questionnaire, using an approach based on the magnitudes of change. (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 NCT02382497, which also lists 2 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 19 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.