Neurofeedback for Attention Deficit Disorder in preschoolers (NeFAP): A randomized, sham-controlled, efficacy study protocol of a novel non-pharmacological therapy

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Alba Pugliesi MD
Niraj Mehta MD PhD
Daniel Guimarães Silva
Jennifer P. Khouri López MD
Cornelis Anibal Luna Fuerte MD
Nicolas Nuñez-Ordonez MD
Suzy Krimon
Omar Kotb
Sahilly Adelina Rodríguez-Martínez MD
Janaina Lima
Douaa Omer Mohamed MPH BDS CPHQ
Cristiane Paulain David MD
Nathalia Satoo Demian F.
Joyce Macedo da Silva MD
Adriana Yock-Corrales MD MSc.

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.

Article Details

How to Cite
Pugliesi, R. A., Mehta, N. ., Guimarães Silva , D., Khouri López, J. ., Luna Fuerte, C. A., Nuñez-Ordonez , N. ., Krimon, S., Kotb, O., Rodríguez-Martínez , S. A. ., O. Lima, J., Omer Mohamed , D. ., David, C. P., Satoo Demian , N. ., Macedo da Silva, J., & Yock-Corrales , A. (2022). Neurofeedback for Attention Deficit Disorder in preschoolers (NeFAP): A randomized, sham-controlled, efficacy study protocol of a novel non-pharmacological therapy. Principles and Practice of Clinical Research, 8(2). https://doi.org/10.21801/ppcrj.2022.82.7
Section
Clinical Research Design
Author Biographies

Alba Pugliesi MD, Klinikum Ludwigsburg, Institut für Interventionelle Radiologie, Posilipostraße 4, Zip Code: 71640, Ludwigsburg, Germany.

Klinikum Ludwigsburg ; (radiology resident).

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.

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.

Medical Student, Faculdade de Medicina da Bahia, Universidade Federal da Bahia, Av. Reitor Miguel Calmon, S/N - Vale do Canela, Salvador - BA, Brasil. 

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

Oftalmolaser, Servicios de Salud Visual, MD.

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.

Faculty of Health Science,Department of Medicine, Universidad Autónoma de Santo Domingo (UASD)-Primada de America, Alma Mater, Santo Domingo, República Dominicana. MD.

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

Pontificia Universidad Javeriana. Clinical Professor, Faculty of Medicine, Universidad de los Andes, Bogotá, Colombia.

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).

PharmD. PPD, part of Thermo Fisher Scientific. São Paulo, SP, Brazil.

Omar Kotb , BPharm, Phoenix Clinical Research. Cairo, Egypt (Ibrahim El-Refaey St, 8th District, Nasr City, Cairo, ZIP Code: 12741).

BPharm, Phoenix Clinical Research. Cairo, Egypt.

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.

Faculty of Health Science, Department of Medicine, Pontificia Universidad Católica Madre y Maestra (PUCMM), Santiago, Dominican Republic. MD.

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).

B.S.in Biology, AbbVie Pharmaceuticals via Page Interim. São Paulo, SP, Brasil.

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

Coordinator health promotion, 1st floor, surveillance department, Ministry of Public Health, Al Rumaila, Doha, Qatar.

Cristiane Paulain David MD, Professor of the State University of Amazonas. Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus (Brazil) - AM, 69065-001

Professor of the State University of Amazonas. Av. Carvalho Leal, 1777 - Cachoeirinha, Manaus (Brazil).

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

Medical student at Faculty of Medicine, University of São Paulo.

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).

PhD student at University of Campinas (UNICAMP). Department of Neurology, School of Medical Science, Campinas, 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

Emergency Department. Hospital Nacional de Niños “Dr. Carlos Saenz Herrera”. CCSS. San José, Costa Rica.