E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention Deficit-Hyperactivity Disorder |
déficit de atención / hiperactividad |
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E.1.1.1 | Medical condition in easily understood language |
Attention deficit disorder with or without hyperactivity |
trastorno por déficit de atención con o sin hiperactividad |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003736 |
E.1.2 | Term | Attention deficit/hyperactivity disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the present study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device ADHD@Home versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder. |
El principal objetivo del presente estudio es demostrar la no inferioridad del dispositivo personalizado Entrenamiento Neurofeedback ADHD@Home frente Metilfenidato en el tratamiento de niños y adolescentes con trastorno por déficit de atención / hiperactividad. |
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E.2.2 | Secondary objectives of the trial |
Furthermore, it is aimed to learn more about the mechanisms underlying Neurofeedback (including the study of biomarkers) |
Por otra parte, se pretende aprender más acerca de los mecanismos que subyacen a Neurofeedback (incluyendo el estudio de biomarcadores) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Children or adolescents (male or female) aged 7-13 years - ADHD diagnosis positive with Kiddie-Sads - ADHD RS IV >6 for attention, with or without hyperactivity - Patient having already had corrective actions for ADHD (formal and informal educational support, psychoeducation, psychotherapy, occupational therapy remediation, at-school programs and remediations) - Signature of inform consent form by parent and child - Wireless internet connection at home |
- Niños o adolescentes (de sexo masculino o femenino) con edades comprendidas entre 7 y 13 años. - Diagnóstico de TDAH confirmado con Kiddie-Sads. - Criterio ADHD RS IV > 6 para falta de atención, con o sin hiperactividad. - El paciente ya ha recibido medidas correctivas para el TDAH (apoyo educativo formal e informal, psicoeducación, psicoterapia, soluciones de terapia ocupacional, programas en el colegio y remedios). - Formulario de consentimiento informado firmado por los padres y el niño. - Conexión a Internet sin cables en el domicilio. |
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E.4 | Principal exclusion criteria |
- ADHD hyperactive/Impulsive without inattention component - Established diagnosis of epilepsy or other neurological disorders - Severe psychiatric disorder other than ADHD diagnosed with Kiddie-Sads such as autism, schizophrenia, severe generalized anxiety disorder, major depression or severe tics - Patient with comorbid disorder requiring psychoactive medication other than ADHD medication - Patient having already been treated with psycho-active drug (MPH and others) or EEG-NF for ADHD in the last 6 months, or more than 4 weeks more than 6 months ago - Unable to use the solution (tablet use and/or headset set-up and/or understanding instructions) according to the investigator - Absence of wireless internet connection at home - Medical disorder requiring systemic chronic medication with confounding psychoactive effects - IQ < 80 using the 3 subtest form of the WASI or the WISC - Plans to move requiring centre change during the next 6 months - Plans to start other ADHD treatment, including psychotherapy, cognitive behaviour training in the next 6 months - Patient with chronic medical illness such as seizure, cardiac disorders, untreated thyroid disease or glaucoma (contra-indication for treatment with MPH) - Significant suicidal risk based on clinical opinion |
- Hiperactividad/impulsividad en TDAH sin componente de falta de atención - Diagnóstico establecido de epilepsia u otros trastornos neurológicos. - Trastorno psiquiátrico severo distinto al TDAH diagnosticado con Kiddie-Sads, como autismo, esquizofrenia, trastorno de ansiedad generalizada severo, depresión mayor o tics severos. - Paciente con trastorno comórbido que requiere medicación psicoactiva distinta a la medicación para el TDAH. - El paciente ya ha sido tratado con un fármaco psicoactivo (MFD y otros) o NF-EEG para el TDAH en los últimos 6 meses o más de 4 semanas hace más de 6 meses. - Incapacidad para usar el sistema (usar la tablet y/o instalar el gorro y/o entender la instrucciones) según el investigador. - No disponer de conexión a Internet sin cables en el domicilio. - Trastornos médicos que precisen medicación sistémica crónica con efectos parecidos a los de los fármacos psicoactivos. - CI < 80 usando las 3 subpruebas de WASI o WISC. - Planes de mudarse que exijan cambiar el centro del estudio en los próximos 6 meses. - Planes de iniciar otro tratamiento para el TDAH, incluida la psicoterapia y la formación cognitivo-conductual en los próximos 6 meses. - Paciente con trastorno médicos crónicos, como convulsiones, trastornos cardíacos, enfermedad tiroidea no tratada o glaucoma (contraindicación para el tratamiento con MFD). - Riego significativo de suicidio basándose en la opinión clínica |
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E.5 End points |
E.5.1 | Primary end point(s) |
change from baseline (inclusion visit Day 0) to end of treatment (last visit Day 90 more or less 10 days) in the Clinician ADHD RS IV total score |
cambio desde el inicio (visita de inclusión) hasta el final del tratamiento (última visita) en la puntuación total ADHD RS IV del médico |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0, Day 60, and Day 90 |
Dia 0, Dia 60 e Dia 90 |
|
E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints: - Clinician ADHD RS IV Inattention and Hyperactivity Score - Clinical responders (a responder is subject with reduction in total clinician ADHD RS score of ≥ 25%) - Parents ADHD RS IV Total, Inattention and Hyperactivity Score - Teacher ADHD RS IV Total, Inattention and Hyperactivity Score - Executive Function Tests by the Behavior Rating Inventory of Executive Function (BRIEF) - The Conners Continuous Performance Test 3rd Edition (Conners CPT 3) - In-school behaviour by the Strengths and Difficulties Questionnaire (SDQ) - Clinical Global Impression of Improvement (CGI-I) and Clinical Global Impressions Scales (CGI-S) - EEG signature evaluation and normalization incl. individual Alpha Peak Frequency, qEEG evolution and learning Biomarkers
Secondary safety/tolerance endpoints: - C-SSRS (Columbia suicide severity rating scale) - Sleep quality with Sleep Disturbance Scale for Children (SDSC) - Pediatric Adverse Event Rating Scale (PAERS) questionnaire - Adverse events analysis - Concomitant medications analysis - Observance |
Criterios de valoración secundarios de la eficacia: - Puntuación ADHD RS IV del médico de falta de atención e hiperactividad - Pacientes con respuesta clínica - Puntuación ADHD RS IV de los padres de falta de atención e hiperactividad - Puntuación ADHD RS IV del profesor de falta de atención e hiperactividad - Pruebas de la función ejecutiva utilizando el inventario de puntuación de la conducta de la función ejecutiva (BRIEF) - Prueba de rendimiento continuo de Conners, 3.ª edición (Conners CPT 3) - Comportamiento en el colegio usando el Cuestionario de aptitudes y dificultades (SDQ) - Impresión global clínica de la mejoría (CGI-I) y Escala de impresiones globales clínicas (CGI-S) - Evaluación y normalización del trazado del EEG incluyendo la frecuencia pico alfa, la evolución qEEG y los biomarcadores de aprendizaje
Criterios de valoración secundarios de seguridad/tolerancia: - C-SSRS (Escala de puntuación de la severidad de las ideas suicidas de Columbia) - Calidad del sueño con la Escala de trastornos del sueño para niños (SDSC) - Cuestionario de la Escala de puntuación de acontecimientos adversos pediátricos (PAERS) - Análisis de los acontecimientos adversos - Análisis de los medicamentos concomitantes - Observancia |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Clinician ADHD RS IV Sub-Scores (D0, D60, D90) - Clinical responders (D90): subjects who will present a decrease of the total clinician ADHD RS score of more or equal to 25% - Parents ADHD RS IV (D0, D60, D90) - Teacher ADHD RS IV (D0, D90) - CGI (severity) (D0, D7, D14, D21, D28, D60, D90) - CGI (improvement) (D7, D14, D21, D28, D60, D90) - BRIEF (D0, D90) - Conners CPT3 (D0, D90) - SDQ (D0, D90) - quantitative Electro-Encephalogram (D0, D60, D90) - C-SSRS (D0, D7, D14, D21, D28, D60, D90) - SDSC (D0, D7, D14, D21, D28, D60, D90) - PAERS (D0, D7, D14, D21, D28, D60, D90) - Physical examination (D0) - Medical/surgical history (D0) - Concomitant treatments collection (D0, D7, D14, D21, D28, D60, D90) - Adverse events collection (D7, D14, D21, D28, D60, D90) |
- Clínico ADHD RS-IV Sub Puntuaciones (D0, D60, D90) - Clínica respondedores (D90): sujetos que presentarán una disminución de la puntuación de ADHD RS clínico total de más o igual al 25% - Los padres ADHD RS IV (D0, D60, D90) - Profesor ADHD RS IV (D0, D90) - CGI (gravedad) (D0, D7, D14, D21, D28, D60, D90) - CGI (mejora) (D7, D14, D21, D28, D60, D90) - BRIEF (D0, D90) - Conners CPT3 (D0, D90) - SDQ (D0, D90) - Cuantitativa electroencefalograma (D0, D60, D90) - C-SSRS (D0, D7, D14, D21, D28, D60, D90) - SDSC (D0, D7, D14, D21, D28, D60, D90) - PAERS (D0, D7, D14, D21, D28, D60, D90) - El examen físico (D0) - Historial médico / quirúrgico (D0) - Recogida de los tratamientos concomitantes (D0, D7, D14, D21, D28, D60, D90) - Recogida de los eventos adversos (D7, D14, D21, D28, D60, D90) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
First administration to humans only for the Medical devices tested |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |