Spinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA
Spinal Cord Injury Service and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, USA.
BMJ Open. 2022 Oct 5;12(10):e064748. doi: 10.1136/bmjopen-2022-064748.
Long pulse width stimulation (LPWS; 120-150 ms) has the potential to stimulate denervated muscles and to restore muscle size in denervated people with spinal cord injury (SCI). We will determine if testosterone treatment (TT)+LPWS would increase skeletal muscle size, leg lean mass and improve overall metabolic health in persons with SCI with denervation. We hypothesise that the 1-year TT+LPWS will upregulate protein synthesis pathways, downregulate protein degradation pathways and increase overall mitochondrial health.
Twenty-four male participants (aged 18-70 years with chronic SCI) with denervation of both knee extensor muscles and tolerance to the LPWS paradigm will be randomised into either TT+neuromuscular electrical stimulation via telehealth or TT+LPWS. The training sessions will be twice weekly for 1 year. Measurements will be conducted 1 week prior training (baseline; week 0), 6 months following training (postintervention 1) and 1 week after the end of 1 year of training (postintervention 2). Measurements will include body composition assessment using anthropometry, dual X-ray absorptiometry and MRI to measure size of different muscle groups. Metabolic profile will include measuring of basal metabolic rate, followed by blood drawn to measure fasting biomarkers similar to hemoglobin A1c, lipid panels, C reactive protein, interleukin-6 and free fatty acids and then intravenous glucose tolerance test to test for insulin sensitivity and glucose effectiveness. Finally, muscle biopsy will be captured to measure protein expression and intracellular signalling; and mitochondrial electron transport chain function. The participants will fill out 3 days dietary record to monitor their energy intake on a weekly basis.
The study was approved by Institutional Review Board of the McGuire Research Institute (ID # 02189). Dissemination plans will include the Veteran Health Administration and its practitioners, the national SCI/D services office, the general healthcare community and the veteran population, as well as the entire SCI community via submitting quarterly letters or peer-review articles.
NCT03345576.
长脉冲宽度刺激（LPWS；120-150ms）具有刺激去神经肌肉和恢复脊髓损伤（SCI）去神经患者肌肉大小的潜力。我们将确定睾酮治疗（TT）+LPWS 是否会增加 SCI 去神经患者的骨骼肌大小、腿部瘦肉量并改善整体代谢健康。我们假设，1 年 TT+LPWS 将上调蛋白合成途径，下调蛋白降解途径，并增加整体线粒体健康。
24 名 18-70 岁男性参与者（慢性 SCI，双侧膝关节伸肌去神经，可耐受 LPWS 范式）将随机分为 TT+远程医疗神经肌肉电刺激或 TT+LPWS。训练课程将每周两次进行 1 年。测量将在训练前 1 周进行（基线；第 0 周），训练后 6 个月（干预后 1）和 1 年训练结束后 1 周（干预后 2）进行。测量包括使用人体测量法、双 X 射线吸收法和 MRI 评估身体成分，以测量不同肌肉群的大小。代谢谱将包括测量基础代谢率，然后抽血测量类似血红蛋白 A1c 的空腹生物标志物、血脂谱、C 反应蛋白、白细胞介素-6 和游离脂肪酸，然后进行静脉葡萄糖耐量试验以测试胰岛素敏感性和葡萄糖效应。最后，进行肌肉活检以测量蛋白表达和细胞内信号；以及线粒体电子传递链功能。参与者将填写 3 天饮食记录，以每周为单位监测他们的能量摄入。
该研究已获得 McGuire 研究所机构审查委员会的批准（ID#02189）。传播计划将包括退伍军人健康管理局及其从业者、国家 SCI/D 服务办公室、一般医疗保健社区和退伍军人群体，以及整个 SCI 社区，方法是提交季度信件或同行评审文章。
NCT03345576。
