Effects of Neurobiological Therapy With Asymmetric Radio-electric Conveyer (REAC) in Diffuse Axonal Injury: a Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Observe if there are significant changes in the electroencephalographic pattern, compared between the groups.
研究概览
简要总结
Background: Severe traumatic brain injury, particularly diffuse axonal injury (DAI), often leads to lasting neurological issues. Cerebral dysfunction in DAI can be evaluated by monitoring cerebral electrical activity (CEA) through EEG. The radio electric asymmetric conveyer (REAC) is a noninvasive method designed to rebalance cellular polarity via endogenous bioelectric fields and modulate CEA. This technique may alter CEA, which can be detected using quantitative EEG (qEEG).
Objective: To assess qEEG changes following DAI and brain wave alterations after a REAC protocol in this group.
Methods: In this prospective, randomized, double-blind clinical trial, DAI patients will be assigned to active or sham groups for 19 sessions of either true or sham REAC following ICU discharge. Interventions include one Neuro Postural Optimization session and 18 NPPO-BWO-G sessions (up to four per day). The main outcome is to evaluate changes in qEEG patterns through population brain electrical mapping after REAC therapies.
详细描述
Traumatic brain injury (TBI) is a leading cause of death and disability globally, significantly affecting the quality of life for patients and caregivers.
In the United States, traumatic brain injury is the leading cause of death for people aged 1 to 45 and a major risk factor for morbidity and mortality in politrauma cases.
Although epidemiological data in Brazil are limited, studies indicate that TBI is a significant public health issue, primarily impacting the country's young and economically active population.
Automobile accidents and falls are primary causes of traumatic brain injury, with incidence rates highest among young adults (20 to 29 years) and individuals over 80 years old.
TBI is a highly heterogeneous condition, with multiple classification systems that emphasize distinct aspects such as the underlying mechanism of injury, clinical severity, radiological characteristics, and pathophysiological processes. These classifications play an important role in standardizing data collection, identifying prognostic factors, and informing the selection of appropriate therapeutic approaches tailored to individual cases.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DAI diagnostic and consent for participation with the next of kin for each eligible patient
排除标准
- •History of chronic neurological conditions
研究组 & 干预措施
ACTIVE
Subjects undergoing active therapy
干预措施: Subjects in the intervention group receive low-frequency radioelectric therapy (Device)
SHAM
Subjects receiving sham therapy
干预措施: Sham, the device simulates a therapy session (Device)
结局指标
主要结局
Observe if there are significant changes in the electroencephalographic pattern, compared between the groups.
时间窗: Six months
次要结局
- Observe if there are significant clinical improvement determined by the Glasgow outcome scale between the groups.(Six months)
- Observe if there are significant clinical improvement determined by the modified Rankin scale between the groups.(six months)
研究者
Sergio Brasil, MD
MD. PhD.
University of Sao Paulo