Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)
研究概览
简要总结
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic.
The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
详细描述
Attention deficit disorder with or without hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic. In the symptomatic triad of inattention, impulsivity and hyperactivity, there is often a psychopathological disorder, a learning and / or sleep disorder. Medication treatment with methylphenidate is the reference in terms of prescription to reduce the symptoms of AD / HD. However, the limitations of its long-term effectiveness, tolerance of side effects, and parental distrust of psychostimulant treatment are gradually opening the door to new therapeutic approaches.
Neurofeedback is considered by the scientific world as a promising and effective neurocognitive learning technique in the treatment of Attention Deficit Disorder with Hyperactivity ADHD and several neurological and psychiatric disorders. Its principle is to increase the patient's ability to regulate his own brain activity, captured by an ElectroEncephaloGram (EEG), after visual and auditory feedback.
In this controlled and randomized research, the investigator will compare the effects of two neurofeedback protocols on the repercussions of AD / HD symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.
Seventy children and adolescents aged 7 to 15 in two groups will benefit from thirty neurofeedback sessions each, either on a so-called Sensory Motor Rhythm (SMR) protocol or on a protocol called Upper Alpha. To date, no studies have identified the effects of a NF Upper Alpha protocol on improving sleep, hyperactivity and comorbidities in patients with ADHD in a controlled and randomized manner. nor on personality dimensions related to the processes of self-regulation of the patient involved in Neurofeedback (NF) treatment.
The investigator expects superior clinical improvement of ADHD symptoms and sleep disorders in the NF upper alpha training group in patients not following any parallel drug or therapy regimen. The investigator expects stability of the effects of treatment after several months of stopping neurofeedback sessions, without taking or recovery of psychostimulant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children or teenagers between 8 and 15 years old included
- •Subject with mixed-type ADHD (attention deficit hyperactivity disorder) diagnosed by a specialist physician in the field and according to Diagnosis and Statistics of Mental Disorders-5 (DSM-5) criteria.
- •Subject of any psychotropic treatment for at least 15 days before inclusion
- •Subject committing not to take any treatment during the study period, nor to participate in another therapeutic treatment in parallel.
- •Subject available and pledging to honor the two weekly neurofeedback sessions for 15 consecutive weeks, and be available for symptom monitoring at 6 months.
- •Child benefiting from a Social Security scheme.
- •Non Inclusion Criteria:
- •Neurological disorders (epilepsy)
- •Trouble of the autistic spectrum
- •Active disorder without hyperactivity (TDA)
- •Bad understanding of the French language
- •Low Intellectual Level (IQ <70 Cognitive Assessment)
- •Lack of understanding of the constraints inherent in the protocol
- •Inability to comply with the constraints of the study throughout its duration
排除标准
- •premature termination of participation, withdrawal of the patient's voluntary informed consent
- •Investigator's or sponsor's decision
- •Withdrawal of consent of subjects or legal guardians
结局指标
主要结局
Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)
时间窗: scores between baseline and after 15 weeks
ADHD symptoms will be assessed using the clinician version of the 18-item Attention-Deficit with Hyperactivity rating scale IV (ADHD-RS). Each item is scored on a 0-3 scale with 0 representing the absence of the behavior/symptom and 3 representing the very frequent and impairing behavior/symptom over the last months. Two subscales compose ADHD-RS: 9-item Inattention subscale (range: 0-27) and a Hyperactivity-Impulsivity subscale (range: 0-27). The total ADHD-RS score is the sum of the two subscale scores and ranges from 0 to 54. Effectiveness of a neurofeedback protocol on the training capacity will be defined as a decrease of at least 30% the ADHD-RS total score between baseline, after 15 workout sessions of neurofeedback (2 sessions per week) and another 15 workout sessions of neurofeedback (2 sessions per week). Patients completing the study will therefore have undergone 30 workout sessions of neurofeedback
次要结局
- Sleep quality during a neurofeedback protocol using a questionnaire(between baseline and after 15 weeks and after 6 months)
- Stability of change in ADHD symptoms after 6-month follow-up(scores between 15 weeks and after 6 months)
- Scores on Inattention and Hyperactivity-Impulsivity components of ADHD during a neurofeedback protocol(scores between baseline and after 7weeks and after 15 weeks)
- Executive functions rated during a neurofeedback protocol(scores between baseline and after 15 weeks and after 6 months)
- Clinical Improvement during a neurofeedback protocol and after 6-month follow-up(Evolution between baseline and after 15 weeks and after 6 months)
- Computerized measures of attention and impulsivity during a neurofeedback protocol(at baseline, after 15 weeks and after 6months)