Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Sustained Attention to Response Task
研究概览
简要总结
The overall goal of the proposed project is to perform a preliminary study to assess the potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive test of attention and the outcomes of robot-assisted upper-limb rehabilitation.
详细描述
We plan to explore the use of GVS on the severity of attention span deficits and motor training delivered using a spring-based robot. We intend to carry out the study in a small cohort of traumatic brain injury (TBI) survivors (20 subjects). Subjects with attention span deficits but no significant motor impairments will solely undergo a cognitive test of attention with/without GVS. Subjects with both attention span deficits and significant motor impairments will undergo a cognitive test of attention and robot-assisted upper-limb rehabilitation with/without GVS.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe traumatic brain injury involving cognitive and/or motor deficits.
- •Neurological injury >1 year prior to study enrollment
- •Significant attention deficit
- •For subjects with motor deficits (arms 2 and 3), sufficient voluntary movement and range of motion in the most-affected upper extremity to use the robotic arm system (Armeo Spring)
排除标准
- •Pregnancy
- •History of seizures within 6 months of study enrollment
- •Major depression
- •Cognitive impairment that may interfere with understanding instructions
- •Severe limitations of upper extremity range of motion
- •Agitation
- •Other major neurological or psychiatric diseases
- •Participation in other forms of therapy/ intervention for upper extremity motor recovery
- •End-stage liver, kidney, cardiac or pulmonary disease
- •A terminal medical diagnosis with survival <1 year
- •History of drug or alcohol abuse in the last 3 years
- •Adjustment of, or plan to adjust, psychoactive medications within the preceding 1 month, or within the study period.
- •Current participation in another interventional trial targeting TBI
- •Previous GVS treatment
- •Contraindications to GVS such as implants
结局指标
主要结局
Sustained Attention to Response Task
时间窗: Baseline and end-of-treatment data (up to 2 weeks)
Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.
次要结局
未报告次要终点
研究者
Paolo Bonato
Director, Motion Analysis Lab
Spaulding Rehabilitation Hospital