Hugenholtz H, Humphreys P, McIntyre W M, Spasoff R A, Steel K
Division of Neurosurgery, University of Ottawa, Ontario.
Neurosurgery. 1988 Apr;22(4):707-14. doi: 10.1227/00006123-198804000-00015.
A prospective double-blind study of high cervical spinal cord stimulation conducted in eight moderately disabled, spastic, cerebral palsied children failed to demonstrate any significant improvement over base line function during chronic spinal cord stimulation at either optimal stimulation parameters or random placebo parameters. Chronic stimulation included 4 consecutive months of stimulation for 24 hours each day. Stimulators were randomly programmed at optimal parameters for 2 of the 4 months and at placebo parameters for the remaining 2 months. At the end of each month of chronic stimulation, subjects were assessed with a multidisciplinary test battery that included a self-assessment, specific clinical examinations, tests of gross and fine motor control, neuropsychological and neurophysiological tests, a detailed gait analysis, and video recordings. By 6 months after the completion of the study, only 1 of the 8 subjects continued to use his stimulator on a regular basis, with minimal benefit.
一项针对八名中度残疾、痉挛型脑瘫儿童进行的高颈段脊髓刺激前瞻性双盲研究表明,在慢性脊髓刺激期间,无论是在最佳刺激参数还是随机安慰剂参数下,与基线功能相比均未显示出任何显著改善。慢性刺激包括连续4个月每天刺激24小时。刺激器在4个月中的2个月以最佳参数随机编程,其余2个月以安慰剂参数编程。在慢性刺激的每个月末,使用多学科测试组合对受试者进行评估,该组合包括自我评估、特定临床检查、粗大和精细运动控制测试、神经心理学和神经生理学测试、详细的步态分析以及视频记录。研究完成6个月后,8名受试者中只有1人继续定期使用刺激器,获益甚微。