- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285681
Neurofeedback in Treatment of Attention Deficit Hyperactivity Disorder (ADHD NF)
Effectiveness of Neurofeedback in Treatment of Attention Deficit Hyperactivity Disorder in a Sample of Patients in Tanta, Egypt
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 .
Study Overview
Status
Intervention / Treatment
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
- Collection of socio demographic data using El Gilany and El Wasify scale
The Conners Rating Scale For ADHD
- Performed at base line before starting neurofeedback
- After 15 sessions follow up
- After ending the sessions
Neurofeedback:
- The patients will receive 30 sessions each lasting 50 minutes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tanta, Egypt
- NeuroPsychiatry Department - Faculty of Medicine - Tanta University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Effectiveness of Neurofeedback in treatment of Attention Deficit Hyperactivity Disorder
3- Neurofeedback: - The patients will receive 30 sessions each lasting 50 minutes. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5. The Arabic version of Conners Rating Scale
Time Frame: At the baseline after 35 days after 70 days
|
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:
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At the baseline after 35 days after 70 days
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Collection of socio demographic data using El gilany and ElWasify scale
Time Frame: - Performed at base line
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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,
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- Performed at base line
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurodevelopmental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Attention Deficit Disorder with Hyperactivity
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Biofeedback, Psychology
- Feedback, Psychological
- Neurofeedback
Other Study ID Numbers
- 36264PR1295/7/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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