Alba Pugliesi MD
Klinikum Ludwigsburg, Institut für Interventionelle Radiologie, Posilipostraße 4, Zip Code: 71640, Ludwigsburg, Germany.
Niraj Mehta MD PhD
Department of Internal Medicine, Hospital de Clínicas, Federal University of Paraná, R. Gen. Carneiro, 181 – Alto da Glória, Curitiba – PR, Brasil. Zip Code: 80060-900.
Daniel Guimarães Silva
Medical Student, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Av. Reitor Miguel Calmon, S/N - Vale do Canela, Salvador - BA, Brasil. Zip-code: 40110-100.
Jennifer P. Khouri López MD
Oftalmolaser, Servicios de Salud Visual, Calle Sabana Larga, Esq. C, Proyecto 3, Santiago de los Caballeros, Dominican Republic. Zip-code: 51000
Cornelis Anibal Luna Fuerte MD
Faculty of Health Science,Department of Medicine, Universidad Autónoma de Santo Domingo (UASD)-Primada de America, Alma Mater, Santo Domingo, República Dominicana.
Nicolas Nuñez-Ordonez MD
Pontificia Universidad Javeriana. Clinical Professor, Faculty of Medicine, Universidad de los Andes, Bogotá, Colombia. (Ak. 7#116-5 room 303, Bogotá, Colombia, ZIP code 110111). ORCID: 0000-0003-3584-8602
Suzy Krimon
PharmD. PPD, part of Thermo Fisher Scientific. São Paulo, SP, Brazil (Leopoldo Couto de Magalhães Jr. Street, 758, 6th floor, São Paulo, SP, Brazil ZIP code 04542-000).
Omar Kotb
BPharm, Phoenix Clinical Research. Cairo, Egypt (Ibrahim El-Refaey St, 8th District, Nasr City, Cairo, ZIP Code: 12741).
Sahilly Adelina Rodríguez-Martínez MD
Faculty of Health Science, Department of Medicine, Pontificia Universidad Católica Madre y Maestra (PUCMM), Santiago, Dominican Republic (Duarte Highway,km 1 ½, Santiago de los Caballeros, Dominican Republic. ZIP code 51000). ORCID:0000-0001-5639-9602.
Janaina Lima
B.S.in Biology, AbbVie Pharmaceuticals via Page Interim. São Paulo, SP, Brasil (Jornalista Roberto Marinho. Avenue, 85, 7th floor, Sao Paulo,SP, Brazil ZIP Code 04576-010).
Douaa Omer Mohamed MPH BDS CPHQ
Coordinator health promotion, 1st floor, surveillance department, Ministry of Public Health, Al Rumaila, Doha, Qatar. ORCID: https://orcid.org/0000-0003-0333-5802
Cristiane Paulain David MD
Professor of the State University of Amazonas. Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus (Brazil) - AM, 69065-001
Nathalia Satoo Demian F.
Medical student at Faculty of Medicine, University of São Paulo (Dr Arnaldo Avenue, 455 - São Paulo, SP, Brazil), Zip Code: 01246-903
Joyce Macedo da Silva MD
PhD student at University of Campinas (UNICAMP). Department of Neurology, School of Medical Science (R. Tessália Vieira de Camargo, 126 - Cidade Universitária, Campinas - SP, 13083-887, Brazil).
Adriana Yock-Corrales MD MSc.
Emergency Department. Hospital Nacional de Niños “Dr. Carlos Saenz Herrera”. CCSS. San José, Costa Rica. ORCID: https://orcid.org/0000-0002-8251-243
Abstract
Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is an impairing condition that widely affects a child's life. Current treatment guidelines for preschool-aged children suggest prescribing evidence-based parent or teacher-administered behavior therapy (BT) as the first line of treatment. Psychostimulants can be prescribed for non-respondents and moderate-to-severe cases, but they have side effects. Alternative therapy is neurofeedback, which has already shown effectiveness in the older children population but not in preschoolers. Objective: To evaluate if neurofeedback associated with behavioral therapy is superior in efficacy compared to sham neurofeedback plus behavioral therapy for treating newly diagnosed ADHD in preschoolers.
Methods: This will be a multicenter, randomized, single-blinded, parallel-group, superiority phase III study including 274 patients in five sites. Participants are children aged 4 to 6 years old with a confirmed diagnosis of moderate-severe ADHD by a treating physician. Both groups will receive 48 neurofeedback or sham sessions in 24 weeks plus BT, with 6-month follow-up up to 36 months. The primary outcome is the improvement of ADHD symptoms measured by the ADHD Rating Scale-IV (ADHD-RS-IV). After six months, participants will be allowed to use medication if needed. Therefore, one of our secondary endpoints will be time-to-medication. Two hundred seventy-four participants will be enrolled.
Discussion: The NeFAP study is an innovative study of NF to treat symptoms of ADHD in preschoolers. If positive results are obtained, it may change the treatment landscape for preschoolers who typically have difficulty adhering to drug-based treatments.
