PDF(Pubmed)
Abstract：
BACKGROUND: Individuals with spinal cord injury (SCI) can experience accelerated cognitive aging. Myokines (factors released from muscle cells during contractions), such as brain-derived neurotrophic factor (BDNF), are thought to have beneficial effects on cognition. Neuromuscular electrical stimulation (NMES) was shown to elicit a large release of myokines. However, the effects of NMES on cognitive function have not been studied.
OBJECTIVE: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF.
METHODS: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks.
UNASSIGNED: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up.
CONCLUSIONS: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research.
BACKGROUND: ClinicalTrials.gov (NCT05822297, 12/01/2023).
OBJECTIVE: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF.
METHODS: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks.
UNASSIGNED: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up.
CONCLUSIONS: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research.
BACKGROUND: ClinicalTrials.gov (NCT05822297, 12/01/2023).
摘要：
背景：患有脊髓损伤（SCI）的个体可以经历加速的认知老化。Myokines（在收缩过程中从肌肉细胞释放的因子），例如脑源性神经营养因子（BDNF），被认为对认知有有益的影响。神经肌肉电刺激（NMES）被证明会引起肌细胞的大量释放。然而,NMES对认知功能的影响尚未研究。
目的：提出一项临床试验的研究方案，评估NMES旨在改善认知和BDNF的作用。
方法：将对15名患有L1神经级以上慢性SCI（伤后>12个月）的成年人进行重复的随机三阶段单病例实验设计（SCED），并进行连续多基线时间序列和单臂前瞻性试验。每周3天，共12周。
■主要终点是在基线阶段每周进行3次的认知表现（通过智能手机测试进行评估），随机持续时间为3至8周，12周的干预阶段，和随访阶段3周之后12周的无测量休息期。次要终点是在基线期之前测量的BDNF水平和认知表现的变化，干预前后以及12周随访后。
结论：这将是首次研究12周NMES对SCI患者认知和BDNF水平的影响。SCED结果提供了有关个体治疗效果过程的信息，这些信息可能会指导未来的研究。
背景：ClinicalTrials.gov（NCT05822297，12/01/2023）。
目的：提出一项临床试验的研究方案，评估NMES旨在改善认知和BDNF的作用。
方法：将对15名患有L1神经级以上慢性SCI（伤后>12个月）的成年人进行重复的随机三阶段单病例实验设计（SCED），并进行连续多基线时间序列和单臂前瞻性试验。每周3天，共12周。
■主要终点是在基线阶段每周进行3次的认知表现（通过智能手机测试进行评估），随机持续时间为3至8周，12周的干预阶段，和随访阶段3周之后12周的无测量休息期。次要终点是在基线期之前测量的BDNF水平和认知表现的变化，干预前后以及12周随访后。
结论：这将是首次研究12周NMES对SCI患者认知和BDNF水平的影响。SCED结果提供了有关个体治疗效果过程的信息，这些信息可能会指导未来的研究。
背景：ClinicalTrials.gov（NCT05822297，12/01/2023）。
