Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).
研究概览
简要总结
The purpose of this study is to examine the effects of acupuncture on cerebral blood flow (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury, to determine if those changes correlate with changes in biomarkers of brain health, neuropsychological testing, and symptomatic presentation.
详细描述
The primary aim of this study is to examine the effects of acupuncture on brain function and cognition during the acute 10-day window following mild traumatic brain injury.
Traumatic brain injuries (TBI) affect an estimated 1.7 to 2.3 million Americans every year. As the clinical importance of managing those with TBI grows, it is essential that therapies to help in the recovery and management of post-concussion symptoms are identified. Currently, the number one recommended treatment strategy is physical and cognitive rest, followed by gradual return to daily activities and exercise.
Cerebral blood flow declines following TBI, and can remain in a depressed state for ongoing lengths of time. The cellular vulnerability and symptomatic presentation following TBI is likely due to the metabolic imbalance between decreased cerebral blood flow and increased demand for glucose and adenosine triphosphate production. Animal and human studies have shown that acupuncture at locations both locally on the head and neck, as well as distally on the arms, hands, legs, and feet, can increase cerebral blood flow through the left (L) and right (R) middle cerebral artery (MCA), internal carotid artery (ICA), and basilar artery (BA).
Acupuncture has a long history of use in the treatment of acute and chronic pain, headaches, migraines, nausea, anxiety, and sleep disorders, however, studies specific to the utilization of acupuncture in managing symptoms following TBI are lacking.
The investigators hypothesize that that acupuncture treatments may improve cerebral blood flow resulting in overall improvements in brain function and cognition following TBI. Acupuncture may provide a safe treatment to improve outcomes following a TBI, and increase the rate of recovery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50
- •Documented TBI (for TBI-ACUP and TBI-SHAM arms)
- •Visual acuity and hearing adequate for outcomes testing
- •Fluency in English
- •Ability to provide informed consent
- •Acupuncture naïve
排除标准
- •Significant polytrauma that may interfere with follow-up and outcome assessment
- •Patients with major debilitating baseline mental health disorders that would interfere with the validity of outcome assessment due to TBI
- •Patients on psychiatric hold
- •Patients with major debilitating baseline neurological diseases impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
- •Significant history of pre-existing conditions that would interfere with the likelihood of follow-up and validity of outcome assessment due to TBI
- •Pregnancy in female subjects
- •Prisoners or patients in custody
- •Current participation in an observational or intervention trial for TBI
- •Non-English speakers
结局指标
主要结局
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).
时间窗: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)
Cerebral blood flow velocity was assessed at baseline, post-fight, and post-acupuncture in the TBI-ACUP arm. Cerebral blood flow velocity was assessed at baseline, post fight, and post-sham acupuncture in the TBI-SHAM arm. Cerebral blood flow velocity was assessed at baseline, post exercise, and post-acupuncture in the C-EX arm. Cerebral blood flow velocity was assessed at baseline, and post-acupuncture in the C-ACUP arm. Cerebral blood flow velocity was assessed at baseline, and post-sham acupuncture in the C-SHAM arm.
次要结局
- Changes in Hopkins Verbal Learning Test(At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture)
- Rivermead Post-Concussion Survey(Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only)