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临床试验/NCT03811626
NCT03811626已完成不适用

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial

Institut de Recherche sur la Moelle épinière et l'Encéphale6 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
221
试验地点
6
主要终点
Change in quality of life

研究概览

简要总结

Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Patients aged 18 to 65 who have suffered mTBI, have health care coverage, who understand French, who can be followed for 6 months, and who are able to understand, reply, and cooperate.

排除标准

  • Patient intubated and/or ventilated and/or sedated upon arrival at hospital
  • Patient with injury to the medulla and with neurological signs or multiple injuries (at least 1 of which is life-threatening)
  • Brain injury incurred during a suicide attempt
  • Patient presenting psychiatric or psychological disorders that are debilitating and/or interfere with follow-up and/or evaluation
  • Psychoactive treatment ongoing at the time of injury
  • History of hospitalization in specialized a psychiatric setting and/or sick leave for psychological reasons
  • Patient with a neurological disorder
  • Patient with substance dependence
  • Subject under guardianship or wardship

结局指标

主要结局

Change in quality of life

时间窗: Baseline, 6 months -

Change in quality of life assessed by QOLIBRI (Quality of Life after Brain Injury) Scale - QOLIBRI scale assess health-related quality of life (HRQoL) of individuals after traumatic brain injury. QOLIBRI is a comprehensive questionnaire with 37 items covering six dimensions of HRQoL after TBI. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.

次要结局

未报告次要终点

研究者

发起方
Institut de Recherche sur la Moelle épinière et l'Encéphale
申办方类型
Other
责任方
Sponsor

研究点 (6)

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