Neurofeedback in Treatment of Attention Deficit Hyperactivity Disorder

NCT ID: NCT07285681

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-02-28

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) is a common , chronic , and debilitating disorder . Although pharmacological treatments for ADHD can be easily implemented and are usually effective, their long-term therapeutic effects are still uncertain and adverse events are common, especially sleep problems, decreased appetite, and growth deceleration. Furthermore, psychosocial treatments, such eas parental training and behavioral therapy seem to be effective only during its delivery, and their effects are rarely sustained long-term .

Neurofeedback is a biofeedback method based on the rationale that there is a relationship between surface EEG and the underlying thalamocortical mechanisms responsible for its rhythms and frequency modulations .

Variations in alertness and behavioural control appear directly related to thalamocortical generator mechanisms. The principle of NF is that over time, participants learn operant control of their EEG and change from an "abnormal" state to one resembling that of typically developing children. This process is thought to eventually remediate the symptoms associated with ADHD .

Detailed Description

Attention-deficit/hyperactivity disorder (ADHD) is a common , chronic , and debilitating disorder . Although pharmacological treatments for ADHD can be easily implemented and are usually effective, their long-term therapeutic effects are still uncertain and adverse events are common, especially sleep problems, decreased appetite, and growth deceleration. Furthermore, psychosocial treatments, such eas parental training and behavioral therapy seem to be effective only during its delivery, and their effects are rarely sustained long-term Clinical guidelines for attention-deficit/hyperactivity disorder (ADHD) recommend multimodal treatment approaches, with current evidence suggesting that medication, including methylphenidate and various amphetamine formulations, in conjunction with psychosocial treatment are most effective in the short-term . Medication treatments have large effect size in the acute treatment of ADHD and, when combined with psychosocial treatments, large effects up to 2 years of treatment were observed. Nevertheless, it is widely accepted that further treatments with long-lasting effects have to be developed and evaluated .

Over the last decade, an increasing number of studies investigating non-pharmacological treatments have been published. Neurofeedback (NF), which aims at improving self-regulation of brain activity (most often the electroencephalogram, EEG) using a brain-computer interface, has gained popularity. A promising aspect of neurofeedback is that it may rely on procedural learning, thereby potentially allowing lasting effects and thus longer clinical benefit after completion of neurofeedback treatment In recent years, several randomized control studies (RCTs) and meta-analyses have been published on the efficacy of neurofeedback for children with ADHD, overall with mixed results and interpretations .

Neurofeedback is a biofeedback method based on the rationale that there is a relationship between surface EEG and the underlying thalamocortical mechanisms responsible for its rhythms and frequency modulations .

Variations in alertness and behavioural control appear directly related to thalamocortical generator mechanisms. The principle of NF is that over time, participants learn operant control of their EEG and change from an "abnormal" state to one resembling that of typically developing children. This process is thought to eventually remediate the symptoms associated with ADHD The aim of this study to assess the effectiveness of Neurofeedback in management of Attention Deficit Hyperactivity Disorder in a sample of patients in Tanta city, Egypt

All participants in this study will be subjected to the following

1. Collection of socio demographic data using El Gilany and El Wasify scale

2. The Conners Rating Scale For ADHD

• Performed at base line before starting neurofeedback
• After 15 sessions follow up
• After ending the sessions

3. Neurofeedback:

• The patients will receive 30 sessions each lasting 50 minutes.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Effectiveness of Neurofeedback in treatment of Attention Deficit Hyperactivity Disorder

3- Neurofeedback:

• The patients will receive 30 sessions each lasting 50 minutes.

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: DEVICE

The aim of this study to assess the effectiveness of Neurofeedback in management of Attention Deficit Hyperactivity Disorder in a sample of patients in Tanta city, Egypt

Interventions

Neurofeedback

The aim of this study to assess the effectiveness of Neurofeedback in management of Attention Deficit Hyperactivity Disorder in a sample of patients in Tanta city, Egypt

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants are between 12- 18 years old
• Both sexes are included (males & females).
• Willingness to participate to complete study procedures

Exclusion Criteria

• Unwilling to participate in the study.
• Other Psychiatric disorders.
• Intellectual disability

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mai Ahmed Salem

Lecturer of Neuropsychiatry - Faculty of Medicine - Tanta University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NeuroPsychiatry Department - Faculty of Medicine - Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

36264PR1295/7/25

Identifier Type: -

Identifier Source: org_study_id