跳至主要内容
临床试验/NCT07285681
NCT07285681进行中(未招募)不适用

Effectiveness of Neurofeedback in Treatment of Attention Deficit Hyperactivity Disorder in a Sample of Patients in Tanta, Egypt

Tanta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
5. The Arabic version of Conners Rating Scale

研究概览

简要总结

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 .

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

5. The Arabic version of Conners Rating Scale

时间窗: 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: * 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.

Collection of socio demographic data using El gilany and ElWasify scale

时间窗: - Performed at base line

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,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Ahmed Salem

Lecturer of Neuropsychiatry - Faculty of Medicine - Tanta University

Tanta University

研究点 (1)

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