A Phase 1/2,Open-Label Study to Evaluate the Safety and Efficacy of the International Brain Research Foundation (IBRF) Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Patients With Severe Disorders of Consciousness
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tolerance to treatment
研究概览
简要总结
This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol in patients with severe disorders of consciousness (SDOC).
详细描述
Currently, there are no empirically validated, evidence-based pharmacological interventions for the treatment of Severe Disorders of Consciousness (SDOC). In addition, it is unclear why poly-pharmacological interventions, while more common in the treatment of other disorders (e.g., cancer, chronic pain), have not been embraced for the treatment SDOC; some of the lone agents used in treatment of SDOC patients are not "indicated" for combined treatment.
In addition, the treatment of SDOC traditionally employs the use of single or small combinations of pharmacological agents, with no single pharmacological agent being identified as efficacious or effective. As such, a poly-pharmacological intervention may, inherently, involve pharmacological interactions that were not anticipated by the drug manufacturers or prescribing physicians.
The purpose of this study is to document the safety of the IBRF ACP/MCP and to establish its efficacy for those SDOC patients successfully completing treatment. The IBRF ACP/MCP employs a poly-pharmacological approach aimed at studying arousal states and outcomes in SDOC patients beyond those rates documented in literature.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to ≤ 65 years
- •GCS rating of 3 to 9 (severe impairment)
- •Evidence of an acquired brain injury that severely suppresses consciousness
- •Coma, vegetative state, or minimally conscious state based on definitions of the Mohonk Report
- •If polytrauma, patient is medically stable
排除标准
- •GCS of 10 or greater (moderate to mild impairment)
- •Tracheostomies requiring ventilator support
- •Medical condition that precludes objective assessment (e.g., concurrent Guillain-Barre or other severe peripheral neuropathy, severe critical illness myopathy/polyneuropathy)
- •Onset of injury greater than 12 months post hypoxic ischemic injury (HII)
- •Onset of injury greater than 24 months post traumatic brain injury (TBI)
- •Emergence during the screening period
- •Terminal illnesses, existing severe neuro-developmental disorders, existing chronic degenerative neurological conditions, prior moderate-to-severe TBI, or any stroke syndrome other than transient ischemic attack (TIA), or a prior seizure disorder
- •Patients with an uncontrolled seizure disorder, or seizure disorder can only be controlled with medication that is contra-indicated (e.g., dilantin or phenobarbitol),
- •In the opinion of the attending physician, the patient presents with a cardiac condition that would place them at unacceptable risk, or has a documented ejection fraction (EF) <25%
研究组 & 干预措施
IBRF ACP/MCP Group 1
The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)
干预措施: Polypharmacy using FDA-approved products (Drug)
IBRF ACP/MCP Group 1
The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)
干预措施: Median Nerve Stimulation (MNS) (Device)
IBRF ACP/MCP Group 1
The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)
干预措施: Nutraceutical Supplementation (Dietary Supplement)
IBRF ACP/MCP Group 1
The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)
干预措施: Standard of Care (Other)
Standard of Care Group 2
Standard of Care only
干预措施: Standard of Care (Other)
结局指标
主要结局
Tolerance to treatment
时间窗: Week 12
The percent of patients completing the treatment protocol
Number and Frequency of side effects
时间窗: Week 12
The total number and frequency of side effects experienced by patients based on observations and evaluations of the patients' clinical laboratory tests
Adverse events
时间窗: Week 12
Based on observations of the study patients and evaluations of clinical laboratory tests
次要结局
- orientation log (O-LOG)(Week 12)
- vegetative state (VS)(Week 12)
- minimally conscious state (MCS)(Week 12)
- coma recovery scale-revised (CRS-R)(Week 12)
- disability rating scale (DRS)(Week 12)
- functional assessment measure (FIM)(Week 12)
- Glasgow coma scal (GCS)(Week 12)
- Glasgow outcome scale-extended (GOS-E)(Week 12)