Ensayo clínico Fase 1 de tDCS en Adultos Con TEA y/o TDAH Sin Discapacidad Intelectual
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and tolerability of transcranial direct current stimulation (tDCS) combined with cognitive training in adults with Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD).
The main question it aims to answer is:
Is tDCS safe and well-tolerated in adults with ASD and/or ADHD?
Researchers will compare active tDCS to a sham (placebo-like) stimulation to evaluate safety and tolerability.
Participants will:
Receive either active or sham tDCS for 20 minutes daily over 10 consecutive workdays
Undergo stimulation with the anode placed at F3 and the cathode at Fp2
Complete daily cognitive training exercises using the NeuronUP platform during stimulation
Attend baseline and follow-up assessments to monitor for any side effects or discomfort related to the intervention
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 55 years
- •Clinical diagnosis of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) confirmed via medical records or structured clinical interview
- •Able to provide informed consent
- •Fluent in the language used for assessments and cognitive training tasks
- •Stable medication regimen (if applicable) for at least 4 weeks prior to enrollment
- •Willing and able to attend 10 consecutive weekday sessions and follow-up assessment
排除标准
- •History of epilepsy, seizures, or significant neurological disorder (e.g., traumatic brain injury, stroke)
- •Current diagnosis of psychotic disorder or bipolar disorder
- •Presence of metal implants in the head (excluding dental work), pacemaker, or other contraindications to tDCS
- •Current substance use disorder (within past 6 months)
- •Pregnant or planning to become pregnant during the study period
- •Participation in another intervention study within the last 30 days
- •Any condition that, in the opinion of the investigators, may make participation unsafe or interfere with study procedures
研究组 & 干预措施
Active tDCS + Cognitive Training
Participants in this arm will receive anodal transcranial direct current stimulation (tDCS) at 2 mA for 20 minutes per session over 10 consecutive workdays. The anode will be placed over the left dorsolateral prefrontal cortex (F3) and the cathode over the right frontopolar cortex (Fp2) using the 10-20 EEG system. Stimulation will be administered concurrently with cognitive training using the NeuronUP platform, which includes tasks targeting attention, memory, and executive function.
干预措施: Cognitive Training (Behavioral)
Active tDCS + Cognitive Training
Participants in this arm will receive anodal transcranial direct current stimulation (tDCS) at 2 mA for 20 minutes per session over 10 consecutive workdays. The anode will be placed over the left dorsolateral prefrontal cortex (F3) and the cathode over the right frontopolar cortex (Fp2) using the 10-20 EEG system. Stimulation will be administered concurrently with cognitive training using the NeuronUP platform, which includes tasks targeting attention, memory, and executive function.
干预措施: Transcranial Direct Current Stimulation - Active (Device)
Sham tDCS + Cognitive Training
Participants in this arm will undergo the same setup and procedures as the active tDCS group but will receive sham stimulation, which mimics the sensation of tDCS without delivering current beyond the initial ramp-up/down. They will also complete cognitive training with the NeuronUP platform during each session.
干预措施: Transcranial Direct Current Stimulation - Sham (Device)
Sham tDCS + Cognitive Training
Participants in this arm will undergo the same setup and procedures as the active tDCS group but will receive sham stimulation, which mimics the sensation of tDCS without delivering current beyond the initial ramp-up/down. They will also complete cognitive training with the NeuronUP platform during each session.
干预措施: Cognitive Training (Behavioral)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Throughout the 10-day intervention period and at follow-up (up to 2 weeks post-intervention)
Participants will be monitored for adverse events, side effects (e.g., headache, skin irritation, fatigue), and dropout rates. This will be assessed through participant self-report, clinician observation, and standardized side effect checklists administered during and after each session. The outcome will help determine whether daily tDCS paired with cognitive training is safe and acceptable for adults with ASD and/or ADHD.
次要结局
未报告次要终点