Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as related to tDCS
研究概览
简要总结
In this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tDCS), in the setting of dosage escalation, as a candidate intervention for children with Acquired Brain Injury (ABI).
详细描述
Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury. Limited data have established the safety of tDCS in children with neuropsychiatric and neuromotor disorders. However, these tDCS safety paradigms may not be relevant to children with ABI due to their abnormal brain structure and function, decreased ability to communicate, variable symptomology, and time-consuming care needs that exist in this population.
In this open-label, single-group, dosage escalation study, investigators aim to assess the safety, tolerability, and feasibility of incrementally higher tDCS currents in 10 pediatric patients with ABI on an inpatient rehabilitation unit. The study will include up to three sessions of tDCS (sham, 1mA, and then 2 mA) either over the left dorsolateral prefrontal cortex or over the primary motor cortex based on the goal to evaluate change in either cognitive or motor function. We will also explore whether tDCS improves consciousness in pediatric DOC. Mozart classical music, as a concurrent intervention, will be played during sham, 1 mA, and 2 mA tDCS applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 through 17 years
- •History of acquired brain injury.
- •Currently inpatient at the Kennedy Krieger Rehabilitation Unit.
- •Parent and child proficient in English.
排除标准
- •Patients with extensive focal lesions in the left dorsolateral prefrontal cortex (DLPFC) and bilateral primary motor cortex as determined by review of imaging and/or imaging reports obtained as part of clinical care.
- •Youth with known seizures in the month prior to study enrollment.
- •Participants with non-convulsive seizures and/or interictal epileptiform discharges observed on study screening extended EEG.
- •Females with confirmed pregnancy on urine test.
- •Youth with history of craniotomy surgery, metallic cerebral, cochlear or electronic implant in the head or neck area, or ventricular shunt or pacemaker.
- •Patients requiring daytime mechanical ventilation.
- •Children with head circumference less than 43 cm
- •Bilateral severe or profound hearing loss
- •Presence of hairstyle interfering with tDCS application and/or high quality EEG signal
- •Youth in foster care.
结局指标
主要结局
Number of participants with adverse events as related to tDCS
时间窗: Up to 26 Days
The information on number of participants with adverse events will be collected from the beginning of sham tDCS until the end of the last tDCS session.
Changes in pain and discomfort as a measure of safety and tolerability
时间窗: Baseline (1-7 days), pre-during-post stimulation (pre-stimulation: within 30 minutes, during: within 20 minutes, post-stimulation: within 30-minutes)
Face, Legs, Activity, Cry and Consolability Scale (FLACC) Questionnaire: Assessment of change from baseline and post-sham stimulation to pre-during-post stimulation (1 mA, 2 mA) using an observation tool that will measure pain and discomfort as related to transcranial direct current stimulation (tDCS) in children with decreased communication and cognitive impairment.
Disruption of Care Form
时间窗: Up to 26 Days
Questionnaire: Assessment of interruption of inpatient care due to child's participation in the study.
Family Feedback Form
时间窗: 5 days after the end of the last stimulation session.
Questionnaire: Assessment to receive feedback about the satisfaction in the study from the parent/guardian/caregiver of the participant.
Changes in adverse events (skin problems and/or seizures) as a measure of safety
时间窗: Baseline (1-7 days), post-stimulation (within 30-minutes), follow-up (24 hours, 48 hours, 5 days)
Adverse Event Form Questionnaire: Assessment of change from baseline and post-sham stimulation to post- stimulation (1 mA, 2 mA) and follow-up using a detailed assessment of participant's symptoms (skin problems and/or seizures) as related to transcranial direct current stimulation (tDCS) intervention.
次要结局
- Changes in Neurobehavioral functioning(Up to 4 months)