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

NCT05635318 | Unknown

• 1 other identifier: QEEG-NF for ADHD
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Improvement of ADHD manifestations

  Greater improvement in ADHD score between group B and Group A

  6 months

Secondary Outcomes (1)

• Improvement of intelligence

  1 year

Study Arms (2)

Group A

PLACEBO COMPARATOR

Group A including ADHD patients who will be treated according to The American academy of Pediatrics Guidelines with FDA-approved medications

Drug: FDA approved medications for ADHD

Group B

ACTIVE COMPARATOR

Group A including ADHD patients who will be treated according to The American academy of Pediatrics Guidelines with FDA-approved medications plus Quantitative EEG Neurofeedback

Device: FDA approved medications for ADHD plus Quantitative EEG Neurofeedback

Interventions

FDA approved medications for ADHD plus Quantitative EEG Neurofeedback DEVICE

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.

Also known as: Drugs + QEEG-NF

Group B

FDA approved medications for ADHD DRUG

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

Also known as: Drugs

Group A

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed with ADHD according to DSM-5 Criteria for ADHD Age group: 4 years up to less than 16 years

You may not qualify if:

• \*Any patient with other neurological or psychological diseases e.g. Epilepsy, Autism, Cerebral palsy
• Any patient in a different age group

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Arns M, Drinkenburg W, Leon Kenemans J. The effects of QEEG-informed neurofeedback in ADHD: an open-label pilot study. Appl Psychophysiol Biofeedback. 2012 Sep;37(3):171-80. doi: 10.1007/s10484-012-9191-4.

  PMID: 22446998 BACKGROUND

• Krepel N, Egtberts T, Sack AT, Heinrich H, Ryan M, Arns M. A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction. Neuroimage Clin. 2020;28:102399. doi: 10.1016/j.nicl.2020.102399. Epub 2020 Aug 25.

  PMID: 32891892 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dosage Forms; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

El-Sayed Khalil Abdel-Karim, Professor

CONTACT

01556588807; Khalilsay53@aun.edu.eg

Tarek Elsayed Ismail Omar, Professor

CONTACT

01222668880; tarek.omar@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed Emad Eldaly

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 2, 2022

Record last verified: 2022-11