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Quantitative EEG Neurofeedback as an Add-on Therapy For Attention-deficit Hyperactivity Disorder (ADHD)

NCT05635318 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-12-02

No results posted yet for this study

Summary

Attention deficit/hyperactivity disorder (ADHD) is a common neurological disorder in children, mainly manifesting as attention deficit, excessive hyperactivity, and impulsivity. It is a chronic condition that affects millions of children and often continues into adulthood.

The prevalence of ADHD in the worldwide is approximately 5%, predominantly occurring in boys, and more than half of patients continue to experience symptoms into adulthood. Children with ADHD have moral disorders and learning difficulties, and these factors will seriously affect their academic achievements and familial and social relationships; thus, treatment is necessary.

Currently, the treatment for ADHD is usually pharmacological intervention, such as methylphenidate, Atomoxetine…. etc. However, research has suggested that pharmacological intervention has side effects on nervous system development in children, and the long-term efficacy is uncertain. In recent years, the efficacy of neurofeedback (NF) therapy, as a type of biofeedback method, has been proven in many diseases, such as mild cognitive impairment, epilepsy, and autism, depression, and anxiety.

NF converts signals such as EEG into visual or auditory information, and then subjects selectively enhance or inhibit certain components through training. There are three common NF protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow cortical potentials (SCP) training. This study adopts the theta/beta NF protocol. As a promising nonpharmacological alternative treatment for ADHD, the efficacy of NF has been proven in many studies.

The use of quantitative EEG neurofeedback as an add-on therapy can be markedly beneficial to shorten the period of pharmacological treatment and with minimal side effects.

Conditions

  • ADHD

Interventions

DEVICE

FDA approved medications for ADHD plus Quantitative EEG Neurofeedback

A mathematical approach to analyzing EEG data, called quantitative electroencephalography (qEEG), can be used to develop a visual map of the type and location of brain waves or rhythms. Other more specific wave patterns, such as event-related potentials, can also be seen in the EEG.NF converts signals such as EEG into visual or auditory information, and then subjects selectively enhance or inhibit certain components through training. There are three common NF protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow cortical potentials (SCP) training.

DRUG

FDA approved medications for ADHD

Ritalin (methylphenidate HCl); Ritalin LA, Ritalin SR Strattera (atomoxetine HCl)

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-01
Completion
2024-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635318 on ClinicalTrials.gov