Preliminary Efficacy of a Novel EEG-guided Cognitive Pacing Tool During Concussion Recovery: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Immediate Post-Concussion Assessment and Cognitive Testing score
研究概览
简要总结
This investigation will assess the utility of a novel wearable electroencephalography (EEG) headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a mental break. Personalized cloud-based machine learning algorithms will analyze EEG data in real-time for neural features indicative of mental workload and mental fatigue, and will notify a patient when it is time to rest based on these measures. It is hypothesized that this technology may provide a much needed data-driven management tool to better inform the cognitive pacing process for both patients with concussion, as well as their clinicians.
详细描述
Despite advancements in the field of concussion care, the individualized nature and nuances of concussion make it a difficult condition to manage. It has been shown that both complete rest or too much activity can prolong recovery from concussion, indicating there is an ideal zone of activity that can aid in concussion recovery. Heart-rate guided sub-symptom aerobic physical activity has been shown to speed concussion recovery and provide an objective measure for patients with concussion to inform their rehabilitative physical activities. However, no such equal exists for guiding cognitive pacing.
This study will utilize a wearable EEG headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a mental break. Personalized cloud-based machine learning algorithms will analyze EEG data in real-time for neural features of mental workload and mental fatigue, and will notify a patient when it is time to rest based on these measures. These algorithms have been developed and validated on healthy participants, and refined in concussion patients in an ongoing observational investigation yet to be published. The proposed investigation is a randomized, prospective pilot study to test the early efficacy of this technology in concussion recovery compared to standard of care alone. The results of this pilot investigation will be used to inform a future large-scale clinical trial to confirm the efficacy of this technology on concussion recovery.
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
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals are eligible to participate if they meet all of the following criteria:
- •has been diagnosed with a concussion within previous 6 weeks;
- •are between >16 and <55 years of age;
- •fluent in English;
- •able to attend the baseline testing session within 6 weeks post-injury;
- •willing and able to comply with the requirements of the study protocol, including use of intervention;
- •able to access a desktop computer or laptop with a colour monitor, reliable internet connection, pointing device,(mouse or trackpad), and modern web browser for administration of ImPACT Version 4.
排除标准
- •Individuals are ineligible to participate if they meet any of the following criteria:
- •do not have access to a desktop computer or laptop with the technical requirements to perform ImPACT testing at their home (as described above);
- •uncontrolled epilepsy (seizure within 6 months), uncontrolled chronic recurrent migraines, or other neurological disorders that may interfere with concussion recovery and assessment;
- •any signs of dementia or other pre-existing cognitive impairment that would prevent them from giving free, informed consent;
- •have an implantable electrical device;
- •any evidence of the following in addition to concussion diagnosis:
- •documentation that the concussion they had sustained was associated with a Glasgow Coma Scale score ≤ 12 (if available),
- •any findings of trauma on neuroimaging such as brain contusion or hematoma (if available), and
- •any evidence of skull fractures of bony injuries that would require additional rehabilitation.
结局指标
主要结局
Immediate Post-Concussion Assessment and Cognitive Testing score
时间窗: Baseline, post-intervention (2 weeks)
Change in neurocognitive health and changes in concussion recovery. Higher score indicates improvement.
次要结局
- Study inclusion rate and completion rate to indicate feasibility(Baseline, post-intervention (2 weeks))
- Rivermead Post-Concussion Symptoms Questionnaire Outcomes(12 weeks)
- Change in Sports Concussion Assessment Tool score(Baseline, post-intervention (2 weeks))
研究者
Dr. Matthew Kennedy
Principal Investigator
Neurovine Inc.