New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment
NCT ID: NCT02382497
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2014-07-31
2023-07-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AN Active tDCS
Treatment "as usual" plus experimental treatment
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.
AN Sham tDCS
Treatment "as usual" plus placebo treatment
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.
BED Active tDCS
Treatment "as usual" plus experimental treatment
BED 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.
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 tDCS
Treatment "as usual" plus placebo treatment
BED Sham tDCS
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.
Interventions
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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.
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.
BED 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.
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 tDCS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
10 Years
18 Years
ALL
No
Sponsors
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Mariella Enoc
OTHER
Responsible Party
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Mariella Enoc
Responsible of the Child Neuropsychiatry Unit
Principal Investigators
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Stefano Vicari
Role: STUDY_CHAIR
Bambino Gesù Hospital and Research Institute
Floriana Costanzo
Role: PRINCIPAL_INVESTIGATOR
Bambino Gesù Hospital and Research Institute
Locations
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Bambino Gesù Hospital and Research Institute
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Chiara Mennini
Role: primary
Rita Alparone
Role: backup
References
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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.
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.
Other Identifiers
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763_OPBG_2014
Identifier Type: -
Identifier Source: org_study_id