School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Department of Neurology, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Brain Inj. 2022 Mar 21;36(4):553-559. doi: 10.1080/02699052.2022.2059816. Epub 2022 Apr 6.
Traumatic brain injury (TBI) is a major cause of death and disability. TBI can result in neuropsychiatric and cognitive problems as well as neurodegenerative pathologies that can appear right after or develop and persist years after injury.
We conducted a double-blind, randomized, placebo-controlled clinical trial on patients who suffered from TBI three months to three years ago. The patients were randomized to placebo (n = 34) or K-Vie™ group (n = 46) for a treatment period of 3 months. The main primary outcomes include cognitive assessment in the Rey Auditory Verbal Learning Test-Recognition Test (RAVLT), Wechsler adult intelligence Digit Symbol Substitution Test (DSST) and trail-making test part B (TMT-B). Assessments were performed at baseline and at the month 3 follow-up visit. Linear mixed models were carried out to evaluate cognitive changes from baseline across all cognitive assessment tests.
The current study showed significant (p < 0.05) improvement in cognitive function of patients who were given K-Vie™ compared with placebo across the RAVLT, DSST and TMT-B performance assessments. A larger cohort would be beneficial to further confirm the clinical utility of K-Vie™ and assess its effects in acute phases of TBI.
创伤性脑损伤（TBI）是死亡和残疾的主要原因。TBI 可导致神经精神和认知问题以及神经退行性病变，这些问题可能在受伤后立即出现，也可能在受伤后数年发展和持续存在。
我们对三个月至三年前患有 TBI 的患者进行了一项双盲、随机、安慰剂对照的临床试验。患者被随机分为安慰剂组（n=34）或 K-Vie™ 组（n=46），治疗期为 3 个月。主要的主要结局包括 Rey 听觉言语学习测试-识别测试（RAVLT）、威斯康星卡片分类测试数字符号替代测试（DSST）和连线测试 B 部分（TMT-B）的认知评估。在基线和第 3 个月随访时进行评估。线性混合模型用于评估所有认知评估测试中从基线到认知变化。
本研究表明，与安慰剂组相比，接受 K-Vie™治疗的患者在 RAVLT、DSST 和 TMT-B 表现评估中的认知功能有显著（p<0.05）改善。更大的队列将有助于进一步确认 K-Vie™的临床效用，并评估其在 TBI 急性期的作用。
