Effects of Transcranial Direct Current Stimulation (tDCS) Combined with a Developed Cognitive Training Module in Children and Adolescents with ADHD: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in Working Memory, Response Inhibition and Attention
研究概览
简要总结
Aim for Phase 1: To develop and validate a digital cognitive training (CT) module targeting working memory, response inhibition and attention. H1: The cognitive training module will lead to significant changes in the participants’ working memory, response inhibition and attention. H2: The developed cognitive training module will be rated as acceptable and user-friendly by the participants.
Aim for Phase 2: To investigate the effects of transcranial direct current stimulation (tDCS) with and without cognitive training on working memory, response inhibition and attention in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). H1: There will be a significant difference in working memory, response inhibition and attention following tDCS. H2: There will be a significant difference in cognitive outcomes between the group receiving tDCS combined with cognitive training and the groups receiving tDCS alone or cognitive training alone. H3: There will be significant differences in neurophysiological markers (spectral values, HbO, and HbR) among the three groups: tDCS with cognitive training, tDCS alone, and sham tDCS with cognitive training.
A gamified cognitive training module will be developed using JAVA. The module will be validated on five children and adolescents with ADHD. For phase 2, participants will be recruited from the Psychiatry OPD of AIIMS and will be screened for IQ using MISIC. Baseline assessment will be done, followed by allocation of participants into one of the three groups in the study, with an allocation ratio of 1:1:1. After five days of intervention, post-assessment will be conducted. Participants who comply with extra sessions will undergo five more sessions. Participants will be thanked for their participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of ADHD as per DSM-5 IQ greater than or equal to 80 Availability of at least one parent as an informant Ability to comprehend instructions and cooperate for intervention Ability to read and understand English and/or Hindi.
排除标准
- •Metal implants or skin lesions near electrode site History of epilepsy, seizures, or other known organic neurological disorders Patients with autism, psychosis or bipolar disorder Uncooperative patient/ parent Has not been a part of any interventional trial in previous 3 months Drug-naive or drug-free for at least 48 hours.
结局指标
主要结局
Changes in Working Memory, Response Inhibition and Attention
时间窗: Pre and Post Assessment (after 5 sessions)
次要结局
- Changes in the spectral values and Oxygenated and Deoxygenated Haemoglobin Concentrations in the dlPFC.
研究者
Ananya Gupta
All India Institute of Medical Sciences (AlIMS), New Delhi