Hyperbaric Oxygen Treatment in Autism Spectrum Disorders
关键词
抽象
描述
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interactions. People with ASD often exhibit difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity, inattention, impulsivity, self-harm ..
The increasing prevalence of autism spectrum disorders (approximately 1%) has increased the need for evidence-based treatment to lessen the impact of symptoms.
The ethiopathogenesis of ASD has so far been unclear. Current pathophysiological theories have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune dysregulation and oxidative stress involved in the genesis of this disorder. Based on its anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy has been tried as one of the therapeutic arsenals of adjuvant therapy for autism.
This is a randomized controlled study including nearly 80 patients with ASD who underwent clinical and neuropsychological evaluation before and after HBOT treatment as well as the dosage of the various biochemical and immunological markers. These markers will be assessed before and after the HBOT. Perfusion MRI would also be performed before and after HBO.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 06/02/2020 |
| 提交的预估入学人数: | 07/13/2020 |
| 首次发布: | 07/14/2020 |
| 上次提交的更新: | 07/13/2020 |
| 最近更新发布: | 07/14/2020 |
| 实际学习开始日期: | 05/31/2019 |
| 预计主要完成日期: | 12/31/2020 |
| 预计完成日期: | 01/31/2021 |
状况或疾病
干预/治疗
Device: HBOT Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: HBOT Group will benefit from HBOT | Device: HBOT Group HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100% |
| No Intervention: Control group will benefit from the conventional treatment |
资格标准
| 有资格学习的年龄 | 4 Years 至 4 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - All children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of ASD. This diagnosis was made by child psychiatrists experienced in autism using the DSM-5 criteria and the ADI and the Childhood Autism Rating Scale (CARS) Criteria for non-inclusion : - Children with hearing or visual impairments - Children with unbalanced epilepsy - Children with a contraindication to HBOT - Dysfunction of the immune system Exclusion criteria -Child that havent completed entire protocol |
结果
主要结果指标
1. clinical severity assesement [03 months]
次要成果指标
1. dosage of Inetreleukine 6 [03 months]
2. dosage of TNFα [03 months]
3. Oxidatif stress profil [03 months]
4. dosage of Glutathione peroxidase [03 months]
