NCT07285681

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 .

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

October 1, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 5. The Arabic version of Conners Rating Scale

    The Arabic version of Conners' Rating Scale was developed as a comprehensive checklist for acquiring parental reports of the basic presenting problems for children referred to an outpatient psychiatric setting .The Conners' Comprehensive Behavior Rating Scale is a questionnaire that focuses on behavioral, social, and academic issues in children and adolescents. It can help diagnose \& rate attention deficit hyperactivity disorder .The Arabic version of Conners' Rating scale is composed of 48 items divided on 6 scales. The 6 scales include: conduct disorder, learning problems, psychosomatic problems, impulsivity, hyperactivity \& anxiety It is usually considered normal when scores are less than 60, while scores above 60 are signs of academic, behavioral, or social issues. There are several different classes as well: * A T -score of more than 60 can indicate that the child may have an issue such as ADHD. * A T-score greater than 60 but under 70 may indicate moderately severe issues.

    At the baseline after 35 days after 70 days

  • Collection of socio demographic data using El gilany and ElWasify scale

    Socioeconomic status(SES) is measured by 3 variables: education, occupation and income. While SES has been seen as an inherited factor, in modern society it may migrate on the basis of factors such as occupation, education, income, type of housing, material possessions. The final scale included 7 domains in the form of education , occupation, family, family possession, home sanitation, health care and economic domain with a total score of 84, with a higher score indicating better SES,

    - Performed at base line

Study Arms (1)

Effectiveness of Neurofeedback in treatment of Attention Deficit Hyperactivity Disorder

EXPERIMENTAL

3- Neurofeedback: \- The patients will receive 30 sessions each lasting 50 minutes.

Device: Neurofeedback

Interventions

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

Effectiveness of Neurofeedback in treatment of Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroPsychiatry Department - Faculty of Medicine - Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Neuropsychiatry - Faculty of Medicine - Tanta University

Study Record Dates

First Submitted

October 1, 2025

First Posted

December 16, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations