Sandroff Brian M, Weber Erica, Wylie Glenn R, Wender Carly L A, Goverover Yael, Lercher Kirk, Tong Tien T, Robinson Brionna, Moore Nancy, Salter Amber, DeLuca John, Chiaravalloti Nancy D
Centers for Neuropsychology, Neuroscience, Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, United States of America; Department of Physical Medicine & Rehabilitation, Rutgers NJ Medical School, Newark, NJ, United States of America.
Centers for Neuropsychology, Neuroscience, Traumatic Brain Injury Research, Kessler Foundation, East Hanover, NJ, United States of America; Department of Physical Medicine & Rehabilitation, Rutgers NJ Medical School, Newark, NJ, United States of America.
Contemp Clin Trials. 2023 Nov;134:107331. doi: 10.1016/j.cct.2023.107331. Epub 2023 Sep 19.
This paper describes the protocol for a Phase I/II, parallel-group, blinded randomized controlled trial that compares the effects of 12-weeks of combined learning and memory rehabilitation with either aerobic cycling exercise or stretching on cognitive, neuroimaging, and everyday life outcomes in 60 persons with moderate-to-severe traumatic brain injury (TBI) who demonstrate impairments in new learning. Briefly, participants will undergo baseline testing consisting of neuropsychological testing, neuroimaging, daily life measures, and cardiorespiratory fitness. Following baseline testing, participants will be randomized to one of 2 conditions (30 participants per condition) using concealed allocation. Participants will be masked as to the intent of the conditions. The conditions will both involve supervised administration of an enhanced, 8-week version of the Kessler Foundation modified Story Memory Technique, embedded within either 12-weeks of supervised and progressive aerobic cycling exercise training (experimental condition) or 12-weeks of supervised stretching-and-toning (active control condition). Following the 12-week intervention period, participants will complete the same measures as at baseline that will be administered by treatment-blinded assessors. The primary study outcome is new learning and memory impairment based on California Verbal Learning Test (CVLT)-III slope, the secondary outcomes include neuroimaging measures of hippocampal volume, activation, and connectivity, and the tertiary outcomes involve measures of daily living along with other cognitive outcomes. We further will collect baseline sociodemographic data for examining predictors of response heterogeneity. If successful, this trial will provide the first Class I evidence supporting combined memory rehabilitation and aerobic cycling exercise training for treating TBI-related new learning and memory impairment.
本文描述了一项I/II期平行组双盲随机对照试验的方案，该试验比较了12周联合学习与记忆康复训练（分别结合有氧自行车运动或伸展运动）对60名中度至重度创伤性脑损伤（TBI）且存在新学习障碍患者的认知、神经影像学和日常生活结局的影响。简而言之，参与者将接受包括神经心理学测试、神经影像学检查、日常生活测量和心肺适能测试在内的基线测试。基线测试后，参与者将通过隐蔽分配随机分为2组（每组30名参与者）。参与者将对分组意图不知情。两组都将在监督下进行强化版的8周凯斯勒基金会改良故事记忆技术训练，该训练将分别嵌入12周的监督渐进式有氧自行车运动训练（试验组）或12周的监督伸展和塑形训练（活性对照组）中。在12周的干预期结束后，参与者将完成与基线相同的测量，测量由对治疗不知情的评估人员进行。主要研究结局是基于加利福尼亚言语学习测试（CVLT）-III斜率的新学习和记忆障碍，次要结局包括海马体积、激活和连通性的神经影像学测量，第三结局涉及日常生活测量以及其他认知结局。我们还将收集基线社会人口学数据，以检查反应异质性的预测因素。如果试验成功，将提供首个I级证据，支持联合记忆康复训练和有氧自行车运动训练治疗与TBI相关的新学习和记忆障碍。
