Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT05832060
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004410', 'term': 'Dyslexia'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Text reading accuracy (Experimental reading task)', 'timeFrame': 'during procedure', 'description': 'Change from baseline in text reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.'}], 'secondaryOutcomes': [{'measure': 'Text reading speed (Experimental reading task)', 'timeFrame': 'during procedure', 'description': 'Change from baseline in text reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Text reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).'}, {'measure': 'Experimental reading task: high-frequency word reading accuracy', 'timeFrame': 'during procedure', 'description': 'Change from baseline in high-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.'}, {'measure': 'Experimental reading task: high-frequency word reading speed', 'timeFrame': 'during procedure', 'description': 'Change from baseline in high-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. High-frequency word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).'}, {'measure': 'Experimental reading task: low-frequency word reading accuracy', 'timeFrame': 'during procedure', 'description': 'Change from baseline in low-frequency word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.'}, {'measure': 'Experimental reading task: low-frequency word reading speed', 'timeFrame': 'during procedure', 'description': 'Change from baseline in low-frequency word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Low-frequency word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).'}, {'measure': 'Experimental reading task: non-word reading accuracy', 'timeFrame': 'during procedure', 'description': 'Change from baseline in non-word reading accuracy during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Non-word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.'}, {'measure': 'Experimental reading task: non-word reading speed', 'timeFrame': 'during procedure', 'description': 'Change from baseline in non-word reading speed during Active tDCS and Active tRNS sessions than during Sham tDCS and Sham tRNS sessions. Non-word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Adolescents', 'tRNS', 'transcranial random noise stimulation', 'tDCS', 'transcranial direct current stimulation', 'neurodevelopmental disorders', 'non-invasive brain stimulation', 'transcranial electrical stimulation', 'EEG', 'reading abilities'], 'conditions': ['Developmental Dyslexia']}, 'referencesModule': {'references': [{'pmid': '12114001', 'type': 'RESULT', 'citation': 'Shaywitz BA, Shaywitz SE, Pugh KR, Mencl WE, Fulbright RK, Skudlarski P, Constable RT, Marchione KE, Fletcher JM, Lyon GR, Gore JC. Disruption of posterior brain systems for reading in children with developmental dyslexia. Biol Psychiatry. 2002 Jul 15;52(2):101-10. doi: 10.1016/s0006-3223(02)01365-3.'}, {'pmid': '12604786', 'type': 'RESULT', 'citation': 'Temple E, Deutsch GK, Poldrack RA, Miller SL, Tallal P, Merzenich MM, Gabrieli JD. Neural deficits in children with dyslexia ameliorated by behavioral remediation: evidence from functional MRI. Proc Natl Acad Sci U S A. 2003 Mar 4;100(5):2860-5. doi: 10.1073/pnas.0030098100. Epub 2003 Feb 25.'}, {'pmid': '21173250', 'type': 'RESULT', 'citation': 'Hoeft F, McCandliss BD, Black JM, Gantman A, Zakerani N, Hulme C, Lyytinen H, Whitfield-Gabrieli S, Glover GH, Reiss AL, Gabrieli JD. Neural systems predicting long-term outcome in dyslexia. Proc Natl Acad Sci U S A. 2011 Jan 4;108(1):361-6. doi: 10.1073/pnas.1008950108. Epub 2010 Dec 20.'}, {'pmid': '17050709', 'type': 'RESULT', 'citation': 'Hoeft F, Hernandez A, McMillon G, Taylor-Hill H, Martindale JL, Meyler A, Keller TA, Siok WT, Deutsch GK, Just MA, Whitfield-Gabrieli S, Gabrieli JD. 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Dyslexia-specific brain activation profile becomes normal following successful remedial training. Neurology. 2002 Apr 23;58(8):1203-13. doi: 10.1212/wnl.58.8.1203.'}, {'pmid': '21950776', 'type': 'RESULT', 'citation': 'Stuss DT. The future of cognitive neurorehabilitation. Neuropsychol Rehabil. 2011 Oct;21(5):755-68. doi: 10.1080/09602011.2011.605590. Epub 2011 Sep 27.'}, {'pmid': '28680099', 'type': 'RESULT', 'citation': 'Looi CY, Lim J, Sella F, Lolliot S, Duta M, Avramenko AA, Cohen Kadosh R. Transcranial random noise stimulation and cognitive training to improve learning and cognition of the atypically developing brain: A pilot study. Sci Rep. 2017 Jul 5;7(1):4633. doi: 10.1038/s41598-017-04649-x.'}, {'pmid': '12803972', 'type': 'RESULT', 'citation': 'Nitsche MA, Schauenburg A, Lang N, Liebetanz D, Exner C, Paulus W, Tergau F. Facilitation of implicit motor learning by weak transcranial direct current stimulation of the primary motor cortex in the human. 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Transcranial electrical stimulation improves phoneme processing in developmental dyslexia. Brain Stimul. 2019 Jul-Aug;12(4):930-937. doi: 10.1016/j.brs.2019.02.007. Epub 2019 Feb 13.'}, {'pmid': '25701796', 'type': 'RESULT', 'citation': 'Heth I, Lavidor M. Improved reading measures in adults with dyslexia following transcranial direct current stimulation treatment. Neuropsychologia. 2015 Apr;70:107-13. doi: 10.1016/j.neuropsychologia.2015.02.022. Epub 2015 Feb 19.'}, {'pmid': '26890096', 'type': 'RESULT', 'citation': 'Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Giacomo K, Vicari S, Menghini D. Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. Restor Neurol Neurosci. 2016;34(2):215-26. doi: 10.3233/RNN-150561.'}, {'pmid': '17452283', 'type': 'RESULT', 'citation': 'Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. 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J Neurosci. 2013 Sep 11;33(37):14899-907. doi: 10.1523/JNEUROSCI.1692-13.2013.'}, {'pmid': '24064065', 'type': 'RESULT', 'citation': 'Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.'}, {'pmid': '22820638', 'type': 'RESULT', 'citation': 'Costanzo F, Menghini D, Caltagirone C, Oliveri M, Vicari S. High frequency rTMS over the left parietal lobule increases non-word reading accuracy. Neuropsychologia. 2012 Sep;50(11):2645-51. doi: 10.1016/j.neuropsychologia.2012.07.017. Epub 2012 Jul 20.'}, {'pmid': '29550525', 'type': 'RESULT', 'citation': 'Costanzo F, Rossi S, Varuzza C, Varvara P, Vicari S, Menghini D. Long-lasting improvement following tDCS treatment combined with a training for reading in children and adolescents with dyslexia. Neuropsychologia. 2019 Jul;130:38-43. doi: 10.1016/j.neuropsychologia.2018.03.016. Epub 2018 Mar 14.'}, {'pmid': '26848997', 'type': 'RESULT', 'citation': 'Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Koch G, Vicari S, Menghini D. Reading changes in children and adolescents with dyslexia after transcranial direct current stimulation. Neuroreport. 2016 Mar 23;27(5):295-300. doi: 10.1097/WNR.0000000000000536.'}, {'pmid': '22031888', 'type': 'RESULT', 'citation': 'Fertonani A, Pirulli C, Miniussi C. Random noise stimulation improves neuroplasticity in perceptual learning. J Neurosci. 2011 Oct 26;31(43):15416-23. doi: 10.1523/JNEUROSCI.2002-11.2011.'}, {'pmid': '23684971', 'type': 'RESULT', 'citation': 'Snowball A, Tachtsidis I, Popescu T, Thompson J, Delazer M, Zamarian L, Zhu T, Cohen Kadosh R. Long-term enhancement of brain function and cognition using cognitive training and brain stimulation. Curr Biol. 2013 Jun 3;23(11):987-92. doi: 10.1016/j.cub.2013.04.045. Epub 2013 May 16.'}, {'pmid': '22305346', 'type': 'RESULT', 'citation': 'Turkeltaub PE, Benson J, Hamilton RH, Datta A, Bikson M, Coslett HB. Left lateralizing transcranial direct current stimulation improves reading efficiency. Brain Stimul. 2012 Jul;5(3):201-207. doi: 10.1016/j.brs.2011.04.002. Epub 2011 May 5.'}, {'pmid': '22916214', 'type': 'RESULT', 'citation': 'Linkersdorfer J, Lonnemann J, Lindberg S, Hasselhorn M, Fiebach CJ. Grey matter alterations co-localize with functional abnormalities in developmental dyslexia: an ALE meta-analysis. PLoS One. 2012;7(8):e43122. doi: 10.1371/journal.pone.0043122. Epub 2012 Aug 20.'}, {'pmid': '16427357', 'type': 'RESULT', 'citation': 'Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.'}, {'pmid': '20471313', 'type': 'RESULT', 'citation': 'Ambrus GG, Paulus W, Antal A. Cutaneous perception thresholds of electrical stimulation methods: comparison of tDCS and tRNS. Clin Neurophysiol. 2010 Nov;121(11):1908-14. doi: 10.1016/j.clinph.2010.04.020. Epub 2010 May 14.'}, {'pmid': '33561725', 'type': 'RESULT', 'citation': 'Berger I, Dakwar-Kawar O, Grossman ES, Nahum M, Cohen Kadosh R. Scaffolding the attention-deficit/hyperactivity disorder brain using transcranial direct current and random noise stimulation: A randomized controlled trial. Clin Neurophysiol. 2021 Mar;132(3):699-707. doi: 10.1016/j.clinph.2021.01.005. Epub 2021 Jan 27.'}, {'pmid': '32029377', 'type': 'RESULT', 'citation': 'Breitling C, Zaehle T, Dannhauer M, Tegelbeckers J, Flechtner HH, Krauel K. Comparison between conventional and HD-tDCS of the right inferior frontal gyrus in children and adolescents with ADHD. Clin Neurophysiol. 2020 May;131(5):1146-1154. doi: 10.1016/j.clinph.2019.12.412. Epub 2020 Jan 24.'}, {'pmid': '25426043', 'type': 'RESULT', 'citation': 'Paulesu E, Danelli L, Berlingeri M. Reading the dyslexic brain: multiple dysfunctional routes revealed by a new meta-analysis of PET and fMRI activation studies. Front Hum Neurosci. 2014 Nov 11;8:830. doi: 10.3389/fnhum.2014.00830. eCollection 2014.'}, {'pmid': '22711189', 'type': 'RESULT', 'citation': 'Richlan F, Kronbichler M, Wimmer H. Structural abnormalities in the dyslexic brain: a meta-analysis of voxel-based morphometry studies. Hum Brain Mapp. 2013 Nov;34(11):3055-65. doi: 10.1002/hbm.22127. Epub 2012 Jun 19.'}, {'pmid': '22516793', 'type': 'RESULT', 'citation': 'Vandermosten M, Boets B, Wouters J, Ghesquiere P. A qualitative and quantitative review of diffusion tensor imaging studies in reading and dyslexia. Neurosci Biobehav Rev. 2012 Jul;36(6):1532-52. doi: 10.1016/j.neubiorev.2012.04.002. Epub 2012 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD.\n\nThe investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.', 'detailedDescription': "The study design is within-subject, randomized stratified, double blind, placebo-controlled.\n\nA group of children and adolescents with DD will be selected and exposed to three different conditions with an interval-session of at least 6 days: 1. tRNS over bilateral TPC; 2. anodal tDCS over left TPC (cathode over right TPC); 3. sham tRNS or tDCS. During stimulation (both real and sham), participants will undergo a concomitant reading task.\n\nIn this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS and tDCS, can improve the outcome of individuals with DD.\n\nThe protocol will allow the investigators to:\n\n* comparing the efficacy of tDCS and tRNS over TPC in improving reading abilities,\n* comparing the safety and tolerability of tDCS and tRNS in children and adolescents.\n\nThe investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD, based on the two most used brain stimulation techniques in pediatric population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents with dyslexia (DSM-5, APA 2013)\n* IQ ≥ 85\n\nExclusion Criteria:\n\n* Having a comorbidity with an important medical conditions;\n* Having neurological diseases;\n* Having Epilepsy o family history of epilepsy;\n* Receiving a treatment for dyslexia in the previous three months before the baseline screening.'}, 'identificationModule': {'nctId': 'NCT05832060', 'briefTitle': 'Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia', 'orgStudyIdInfo': {'id': '2639_OPBG_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS, tRNS, Sham', 'description': '1. Active left anodal/right cathodal tDCS over TPC\n2. Active tRNS over bilateral TPC\n3. Sham tRNS or tDCS over bilateral TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'tDCS, Sham, tRNS', 'description': '1. Active left anodal/right cathodal tDCS over TPC\n2. Sham tRNS or tDCS over bilateral TPC\n3. Active tRNS over bilateral TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'tRNS, tDCS, Sham', 'description': '1. Active tRNS over bilateral TPC\n2. Active left anodal/right cathodal tDCS over TPC\n3. Sham tRNS or tDCS over bilateral TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'tRNS, Sham, tDCS', 'description': '1. Active tRNS over bilateral TPC\n2. Sham tRNS or tDCS over bilateral TPC\n3. Active left anodal/right cathodal tDCS over TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Sham, tDCS, tRNS', 'description': '1. Sham tRNS or tDCS over bilateral TPC\n2. Active left anodal/right cathodal tDCS over TPC\n3. Active tRNS over bilateral TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'Sham, tRNS, tDCS', 'description': '1. Sham tRNS or tDCS over bilateral TPC\n2. Active tRNS over bilateral TPC\n3. Active left anodal/right cathodal tDCS over TPC', 'interventionNames': ['Device: Active tDCS', 'Device: Active tRNS', 'Device: Sham tRNS or tDCS']}], 'interventions': [{'name': 'Active tDCS', 'type': 'DEVICE', 'description': 'Active tDCS will be delivered over TPC for a stimulation session. The anodal electrode will be placed on the left TPC, T7/TP7 position according to the 10-20 International EEG 10-20 System for electrode placement. The cathodal electrode will be placed on the right TPC, T8/TP8 position. Intensity will be set at 1 mA, the duration of stimulation will be 20 min.', 'armGroupLabels': ['Sham, tDCS, tRNS', 'Sham, tRNS, tDCS', 'tDCS, Sham, tRNS', 'tDCS, tRNS, Sham', 'tRNS, Sham, tDCS', 'tRNS, tDCS, Sham']}, {'name': 'Active tRNS', 'type': 'DEVICE', 'description': 'Active tRNS will be delivered to bilateral TPC for a stimulation session. The electrodes will be placed on the left and right TPC, respectively T7/TP7 and T8/TP8 position, at 0.75 mA (100-500 Hz) for 20 min.', 'armGroupLabels': ['Sham, tDCS, tRNS', 'Sham, tRNS, tDCS', 'tDCS, Sham, tRNS', 'tDCS, tRNS, Sham', 'tRNS, Sham, tDCS', 'tRNS, tDCS, Sham']}, {'name': 'Sham tRNS or tDCS', 'type': 'DEVICE', 'description': 'Sham tRNS or tDCS will be delivered over bilateral TPC for a stimulation session. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down without the participants awareness.', 'armGroupLabels': ['Sham, tDCS, tRNS', 'Sham, tRNS, tDCS', 'tDCS, Sham, tRNS', 'tDCS, tRNS, Sham', 'tRNS, Sham, tDCS', 'tRNS, tDCS, Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'Bambino Gesù Hospital and Research Institute', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Psychology Unit', 'investigatorFullName': 'Deny Menghini', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}