Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Neurological outcome
研究概览
简要总结
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated significant improvement in neurological or cognitive recovery. Changes in glucose metabolism are considered the hallmark metabolic response to TBI and ketosis has been proposed as a therapy to ameliorate metabolic dysfunction. This trial investigates the therapeutic potential of a ketogenic or modified Atkins diet on neurocognitive outcome following moderate-severe TBI.
详细描述
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated significant improvement in neurological or cognitive recovery. Changes in glucose metabolism are considered the hallmark metabolic response to TBI and ketosis has been proposed as a therapy to ameliorate metabolic dysfunction. Further research is necessary to address the outstanding questions regarding outcome, dose, timing, route and duration of ketogenic diet (KD) or modified Atkins diet (MAD) therapy in clinical TBI. Using a multiparametric MRI and MR spectroscopy approach in conjunction with standardized neurological and neuropsychological assessments of outcome, disability, cognition, and quality of life, this trial will investigate the therapeutic potential of KD/MAD on 12 month outcome following moderate-severe TBI patients.
The purpose of this project is to:
- Determine the effect of KD/MAD on cognitive and neurological outcome following moderate - severe TBI. To date clinical studies of ketone metabolism in TBI are severely limited and have focused primarily on ketometabolism and its effects on glucose metabolism without assessing functional or cognitive outcomes. This project directly assesses the effect of KD/MAD on measures of disability, attention, memory, processing speed, language, and executive function during ketosis and will determine whether its effects outlast the duration of the diet.
- Identify the effects of KD/MAD on cerebral metabolism following moderate - severe TBI. While the use of ketogenic fuels is receiving greater attention, little is known about the effect of the KD/MAD on neuronal metabolism. This project will use MR spectroscopy to non-invasively measure NAA, a marker of neuronal metabolism during ketosis and outside the treatment window, which will deepen our understanding of the neuroprotective mechanisms of this therapy.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complicated mild (GCS 13-15), moderate (GCS 9 - 12) to severe (GCS ≤ 8) traumatic brain injury (TBI) between 2-30 days post injury
- •Admitted to Loma Linda University surgical intensive care unit (SICU)
排除标准
- •history of comorbid ischemic stroke following qualifying TBI
- •history of premorbid brain injury with associated loss of consciousness
- •history of psychiatric disorder
- •history of premorbid neurological disorder or neurosurgical intervention
- •pregnancy
- •depressed GCS score due to acute intoxication
- •liver dysfunction as defined by liver enzymes 5 times the upper limit of normal or chronic cirrhosis
- •acute renal failure according to the Risk, Injury, Failure, Loss of kidney function, and End-stage kidenty disease (RIFLE) classification
- •abdominal surgery during the same admission
- •type 1 diabetes
- •gastroparesis
- •dyslipidemia
- •severe asphasia
- •known history of metabolic disorders that are a contradiction for ketogenic diet (KD) such as primary carnitine deficient, carnitine palmitoyltransferase (CPT) I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency, or porphyria
- •prealbumin (transthyretin) levels of <10 mg/dL within 3 days of admission
- •Metal, implanted device (ICP monitor), pregnancy, claustrophobia, or other contraindication to MRI
研究组 & 干预措施
TBI KD/MAD
TBI subjects on a ketogenic/modified Atkins diet
干预措施: ketogenic/modified Atkins diet (Other)
TBI SD
TBI subjects on a standard (normal) diet
干预措施: Standard diet (Other)
结局指标
主要结局
Neurological outcome
时间窗: day 0 to 12 months
The Disability Rating Scale (DRS) will be used to measure general functional changes as a result of the dietary intervention over a 6 month recovery period. This scale ranges from 0 (without disability) to a maximum score of 29 (extreme vegetative state).
Change in cerebral metabolism
时间窗: day 0 to 12 months
Single voxel magnetic resonance spectroscopy will be used to assess changes in cerebral metabolism as a result of the dietary intervention.
次要结局
- Neurocognitive outcome: Delis Kaplan Executive Function System (D-KEFS)(day 0 to 12 months)
- Neurocognitive outcome: Trail Making Test, Part B(day 0 to 12 months)
- Neurocognitive outcome: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(day 0 to 12 months)
- Neurocognitive outcome: 36 Item Short Form Survey (SF-26)(day 0 to 12 months)
研究者
Brenda Bartnik Olson, PhD
Associate Professor
Loma Linda University