Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial
2022年4月22日 更新者：Guilherme da Cruz Ribeiro Poiani、University of Sao Paulo General Hospital
The Effects of Transcranial LED Therapy (TCLT) in Patients With Traumatic Brain Injury (TBI): a Prospective, Randomized Controlled Trial
The purpose of this study is to evaluate the early and late effects of Transcranial Led Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI history (TBI time longer than 3 months).
研究概览
详细说明
In the current study patients in the outpatient center - Neurotrauma Unit at University of São Paulo (HCFMUSP) diagnosed with moderate / severe blunt head trauma that meet the inclusion criteria will be divided randomly and blindly in two groups: Group A (n = 18) will receive stimulation through active helmet and Group B (n = 18) given placebo stimulation or sham through the inactive helmet.
All patients will be subjected to 3 times of neuropsychological assessment: Study 1 (E1) - up to 4 weeks before the start of TLTC sessions; Study 2 (E2) - a week after the end of TLTC; and Study 3 (E3) - three months after the intervention.
The evaluations will take in order to verify the early and late effects of TLTC in attention, memory and executive functions in patients with moderate and severe TBI.
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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SP
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Sao Paulo、SP、巴西、054010-000
- Clinics Hospital - University of Sao Paulo Medical School
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical and radiological diagnosis of traumatic brain injury
- Must be able to sign the Informed Consent Form
- Patients with TBI beginning three months after injury
Exclusion Criteria:
- Impairment of language and / or limiting engine
- Extensive Cranial vault defects
- Presence of uncontrolled post-TBI epilepsy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active helmet LED
Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (ACTIVE HELMET) with 30 minutes duration each.
The sessions take place over 6 weeks.
The therapy will be performed with a helmet that covers the frontal and parietal region.
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Whereas the geometry of the skull and to uniformly distribute the light radiation, the TLTC is applied using as light source a set of LEDs installed in a helmet, emitting radiation in the range between 600nm and 650nm with a peak at 630nm, so in the red region.
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假比较器：Sham group
Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (INACTIVE HELMET) with 30 minutes duration each.
The sessions take place over 6 weeks.
The therapy will be performed with a helmet that covers the frontal and parietal region.
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A SHAM identical helmet will be used in the control group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evidence of improvement in inhibitory control measured by cognitive assessment (Stroop Test - Victoria Version) in patients undergoing intervention with an active LED helmet.
大体时间：Three times: Up to one week before to start intervention, one week and three months after end the intervention
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Measurement of each patient's inhibitory control by means of a test that causes them to cognitively suppress a habitual response in favor of a less habitual one.
The results of patients with shorter response times indicate better positions in the tables, according to age.
Examples of the average time (in seconds) of best results are between 17-29 years (11.79) and 80+ (19.31), any time longer than these indicates decreasing results.
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Three times: Up to one week before to start intervention, one week and three months after end the intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess the immediate and late effects of the intervention on victims of moderate or severe TBI in the following cognitive domains: executive functioning, attentional processes and memory.
大体时间：Three times: Up to one week before to start intervention, one week and three months after end the intervention
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Apply a neuropsychological assessment battery focused on executive functioning, attentional processes and memory to measure the effects of the active led helmet compared to the use of the sham device.
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Three times: Up to one week before to start intervention, one week and three months after end the intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wellingson S Paiva, MD PhD、Clinics Hospital - University of Sao Paulo Medical School
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年1月1日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年11月1日
研究注册日期
首次提交
2015年2月20日
首先提交符合 QC 标准的
2015年3月13日
首次发布 (估计)
2015年3月19日
研究记录更新
最后更新发布 (实际的)
2022年4月29日
上次提交的符合 QC 标准的更新
2022年4月22日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.