Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
研究概览
简要总结
The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.
详细描述
This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:
- •Head CT scan showing diffuse axonal lesion.
- •CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
- •Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
- •Admission less than 8 hours of trauma.
排除标准
- •History of drug or narcotic abuse.
- •Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
- •Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
- •Psychiatric disorders.
- •Injury severity score ≥3, according to the Abbreviated Injury Scale
研究组 & 干预措施
Active Coil Helmet
The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation.
干预措施: Transcranial LED Therapy (Active coil helmet) (Device)
Inactive Coil Helmet
The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.
干预措施: Transcranial LED Therapy (Inactive coil helmet) (Device)
结局指标
主要结局
Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
时间窗: Before stimulation and 1, 3 and 6 months after first stimulation
Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.
次要结局
- Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.(Before stimulation and 1, 3 and 6 months after first stimulation)
- Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).(Before stimulation and 1, 3 and 6 months after first stimulation)