A Study on Safety and Feasibility of a Session of Transcranial Electrical Stimulation (tDCS "One-shot") in Children and Young Adults With Unilateral Cerebral Palsy (UCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 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 study aims to evaluate the safety and the feasibility of transcranial Direct Current Stimulation (tDCS) session in children and young adults with Unilateral Cerebral Palsy (UCP). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in very short term, Upper Limb (UL) functions.
详细描述
Unilateral Cerebral Palsy (UCP) represents the most frequent form of CP; the upper limb (UL) is generally more affected than the lower limb with an impact in "activity" and "participation" areas. The non-invasive brain stimulation techniques (NIBS), such as transcranial Direct Current Stimulation (tDCS), appear able to modulate neuronal plasticity processes even more late in age attracting great interest for their potential fallout in the field of rehabilitation. The effects of tDCS in recovery of motor function has more investigated in adults, while in the pediatric population studies on safety and efficacy are still few and not conclusive. This study aims to evaluate the safety and the feasibility of tDCS session in children and young adults with UCP both in short term and in follow up (up to 24 hrs after the tDCS session). Secondarily it aims to test the effects of tDCS (real vs sham) in improving, in short term, UL functions. For the study 6 children (aged 10-17 years) and 6 young adults (aged 18-28 years) with UCP will be recruited. Each subject receives, randomly, a real session and a sham session of tDCS with BrainStim Stimulator. Before (T0), immediately after (T1) and after 1 hour and half (T2) to each tDCS session (real or sham) heart rate, blood pressure and UL functions will be measured. Moreover the subject fills in an ad hoc questionnaire on safety at T1 and T2 and, on call, at 24 hours after the sessions (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The medical device randomly assigns, to each subject, the sequence of the type of sessions, so no one knows the kind of session performed.
入排标准
- 年龄范围
- 10 Years 至 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Unilateral Cerebral Palsy
- •Informed consent
排除标准
- •Any contraindication for tDCS
研究组 & 干预措施
real tDCS
one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator. The anode electrode is placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode is placed in the supraorbital region (SO) of the contralateral hemisphere.
干预措施: real tDCS (Device)
Sham tDCS
one-shot of sham tDCS session with BrainStim Stimulator (20 minutes). The montage of the electrodes will be placed as in the experimental session i.e.the anode electrode will be placed in a primary motor cortex (M1) of ipsilesional hemisphere (EEG 10/20 system), while cathode in the supraorbital region (SO) of the contralateral hemisphere.
干预措施: sham tDCS (Device)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
时间窗: The questionnaire will be filled in immediately after the tDCS session (T1), at 1 hour and half from T1 (T2) and, on call, at 24 hours from the tDCS session (T3)
An adapted and child-friendly safety and tolerability questionnaire will be used for children and adolescent, while for young adults a questionnaire already used for this evaluation will be proposed. To explore the long-term safety the questionnaire is enriched with questions about quality of sleep, mood and activities to be answered after 24 hours of tDCS session
次要结局
- Changes in blood pressure [mmHg](At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2))
- Changes in Box and Block Test (BBT)(At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2))
- Changes in Hand Grip(At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2))
- Changes in heart rate [heartbeats per minute](At baseline (T0, before the tDCS session), immediately after the tDCS session (i.e. 20 minutes after T0), at 1 hour and half from T1 (T2))