Results of the Application of 80 Sessions of tDCS for 12 Months in Children Between 6 and 11 Years Old With Autism Spectrum Disorder With Rare Diseases, Genetic Problems or PANDAS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- FFT
研究概览
简要总结
Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS
详细描述
tDCS will be applied to 90 children diagnosed with ASD with Mu activity in one of their two temporal lobes and to another 90 children tDCS will not be applied but rather conventional treatments such as the Denver method, etc., in addition to collecting their electroencephalograms in eyes open condition, evoked potentials will be performed. with Mismatch Negativity paradigm to calculate the P300 wave every 25 sessions with a rest of 5-6 weeks between every 25 sessions and the changes in voltage and frequency of the EEG will be analysed using FFT & PSD, as well as the latencies and amplitudes of its P300 wave.
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
- Single (Investigator)
盲法说明
Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 7 and 15 years old
- •Diagnosis: PDD, ASD or PANDAS
- •Have genetic alterations with geneticist reports like: mutation, random mating between organisms, random fertilization or crossing over (or recombination) between chromatids of homologous chromosomes during meiosis.
- •Natural birth without caesarean or complications
- •Normal Pregnancy
排除标准
- •Head Trauma
- •Brain Injuries like meningitis or encephalitis, including SaRS, Herpes or MERS infections
- •Rare Diseases with Auto-Immune Disease
- •Rare diseases with Endocrinology problems
- •Fever or Biochemical problems in the First Blood Test (First Visit)
- •Vaccines Reactions
研究组 & 干预措施
This group of childs will receive tDCS sessions
This children receive 100 sessions during 12 monts in 4 groups of 25 sessions 2 per week of 30 minutes with a separation between them of at least 72 hours
干预措施: tDCS or Transcranial Direct Current Stimulation (Device)
Sham tDCS
Participants will receive sham transcranial direct current stimulation (tDCS). The device and electrode placement will be identical to the active stimulation groups, but the electrical current will be turned off after a brief initial ramp-up period to mimic the physical sensation of active tDCS without delivering therapeutic stimulation.
干预措施: Sham tDCS (Other)
Traditional ASD approach
The childs receive their tradicional interventions, Risperidone according to child's weight, diet, educational or speech therapies, pictographs.
干预措施: Risperidone (Drug)
结局指标
主要结局
FFT
时间窗: 12 months
Change in Voltage for every frequency band
ERP MMN changes
时间窗: 12 months
Changes in P300 wave amplitude
Power Density Spectrum Changes or PSD
时间窗: 12 Months
Amplitude of the PSD
ERP MMN Changes
时间窗: 12 Monts
Changes in P300 wave latency
次要结局
- Social Skills(12 months)
- Visual Contact(12 months)
- Attention(12 months)
- Language(12 months)
研究者
Citlalli Mellado Balanzar
Research Neuropsychologist
Spanish Foundation for Neurometrics Development