Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
The KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Spinal Cord Ser Cases. 2021 Mar 19;7(1):24. doi: 10.1038/s41394-020-00380-4.
Feasibility and preliminary clinical efficacy analysis in a single-arm interventional study.
We developed a brain-computer interface-triggered functional electrical stimulation therapy (BCI-FEST) system for clinical application and conducted an interventional study to (1) assess its feasibility and (2) understand its potential clinical efficacy for the rehabilitation of reaching and grasping in individuals with sub-acute spinal cord injury (SCI).
Spinal cord injury rehabilitation hospital-Toronto Rehabilitation Institute-Lyndhurst Centre.
Five participants with sub-acute SCI completed between 12 and 40 1-hour sessions using BCI-FEST, with up to 5 sessions a week. We assessed feasibility by measuring participants' compliance with treatment, the occurrence of adverse events, BCI sensitivity, and BCI setup duration. Clinical efficacy was assessed using Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM), as primary outcomes. In addition, we used two upper-limb function tests as secondary outcomes.
On average, participants completed 29.8 sessions with no adverse events. Only one of the 149 sessions was affected by technical challenges. The BCI sensitivity ranged between 69.5 and 80.2%, and the mean BCI setup duration was ~11 min. In the primary outcomes, three out of five participants showed changes greater than the minimal clinically important differences (MCIDs). Additionally, the mean change in secondary outcome measures met the threshold for detecting MCID as well; four out of five participants achieved MCID.
The new BCI-FEST intervention is safe, feasible, and promising for the rehabilitation of reaching and grasping after SCI.
单臂介入研究的可行性和初步临床疗效分析。
我们开发了一种脑机接口触发功能性电刺激治疗（BCI-FEST）系统用于临床应用，并进行了一项介入研究，以（1）评估其可行性，（2）了解其在亚急性脊髓损伤（SCI）患者的上肢康复中应用的潜在临床疗效。
脊髓损伤康复医院-多伦多康复研究所-Lyndhurst 中心。
5 名亚急性 SCI 患者使用 BCI-FEST 完成了 12 至 40 次 1 小时的治疗，每周最多 5 次。我们通过评估参与者对治疗的依从性、不良事件的发生、BCI 敏感性和 BCI 设置时间来评估可行性。使用功能独立性测量（FIM）和脊髓独立性测量（SCIM）作为主要结果来评估临床疗效。此外，我们还使用了两种上肢功能测试作为次要结果。
平均而言，参与者完成了 29.8 次治疗，没有不良事件。只有 149 次治疗中的 1 次受到技术挑战的影响。BCI 敏感性在 69.5%至 80.2%之间，平均 BCI 设置时间约为 11 分钟。在主要结果中，5 名参与者中有 3 名的变化大于最小临床重要差异（MCID）。此外，次要结果测量的平均变化也达到了检测 MCID 的阈值；5 名参与者中有 4 名达到了 MCID。
新的 BCI-FEST 干预措施对于 SCI 后的上肢康复是安全、可行且有前途的。
