Using Transcranial Alternating Current Stimulation With Starstim Home Device to Improve Executive Function in Youths With 22q11.2 Deletion Syndrome: A Randomized Double-blind Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Prevalence of adverse events following tACS (safety and tolerability)
研究概览
简要总结
The purpose of this project is to explore the effects of transcranial alternating current stimulation (tACS) in children, adolescents and young adults with a 22q11.2 microdeletion. The main aim of the present research project is to investigate the effects of repeated, individually tuned high-density (HD) tACS on cognition (i.e., WM performance) and related neuroimaging markers in carriers of the 22q11DS. As cognitive deficits, most notably WM impairment, are among the earliest signs of psychotic disorders, interventions during adolescence aimed at reducing cognitive decline in at-risk individuals may prove effective in delaying or even preventing the later emergence of psychotic symptoms.
详细描述
22q11.2 is the neurogenetic disorder with the highest genetic risk of schizophrenia and early diagnosis allows subjects to be followed from early childhood. Not only does atypical cognitive development precede the emergence of the first psychotic symptoms, but it predicts their later severity and further cognitive decline. Even in subjects which premorbid cognitive functioning is already low due to neurogenetic syndromes, further decline in cognitive abilities indicates an increased risk for the emergence of psychotic symptoms.
psychotic symptoms. Thus, early intervention targeting cognition could potentially mitigate the burden of the disease. Individuals carrying the 22q11.2 microdeletion have a distinctive cognitive profile characterized by a dissociation between verbal and visual-spatial memory capacities, supporting a specific deficit in the processing of visuo-spatial information. Memory deficits are therefore a specific weakness of this population. For this reason, we designed a non-invasive brain stimulation protocol to improve visual working memory (WM) in adolescents and young adults with 22q11DS using individual parameters to account for age individual parameters to account for participant age and anatomical variability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Care providers, outcome assessors, data analysts, and a research assistant who will follow the procedures remotely will be blind. A person in the lab not directly involved in any of the previously mentioned activities will be aware of the randomization for safety reasons.
入排标准
- 年龄范围
- 14 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed genetic diagnosis of 22q11DS
- •Age between 14 and 25 years old
- •Willingness to participate
- •Informed Consent signed by the subject and/or the caregiver(s)
排除标准
- •Deep brain stimulation electrodes
- •Traumatic brain injury
- •Facial metal implants
结局指标
主要结局
Prevalence of adverse events following tACS (safety and tolerability)
时间窗: 1 month (i.e., duration of 20 tACS sessions)
Safety and tolerability of using at-home stimulation in a group of youths with neurodevelopmental disorders (i.e., 22q11DS) with the help of caregivers. It will be measured using a homemade questionnaire assessing the presence and intensity of side effects of tACS (e.g., headache, tingling, skin redness, neck pain). Each side effect will be rated on a intensity scale from 1 (absent) to 4 (severe). In addition, we will assess whether the side effect is associated with tACS, from 1 (no association) to 5 (certain association). This questionnaire is present in the Clinical Report Form (CRF) and will be filled after each stimulation session (both tACS and sham stimulation).
次要结局
- Change in verbal working memory performance using Digit Span subtest (Weschler's child/adult intelligence scale (2004, 2011).(An average of 3 months (i.e., duration of the study protocol))
- Change in the oscillatory response of the brain related to working memory with EEG using time-frequency + cross-frequency coupling analyses(An average of 3 months (i.e., duration of the study protocol))
- Change in visuospatial working memory performance using Leiter-3 scales (Roid, Mille, Pomplun, & Koch, 2013), Testing of Attentional Performance (Zimmermann & Fimm, 2002), and CANTAB software (Cambridge Cognition, 2019)(An average of 3 months (i.e., duration of the study protocol))
- Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA(An average of 3 months (i.e., duration of the study protocol))
- Change in psychotic experiences using Ecological Momentary Assessment (EMA)(An average of 3 months (i.e., duration of the study protocol))
研究者
Stephan Eliez
Professor
University of Geneva, Switzerland