A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Brain Injury
In brief
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).
Key facts
- Study ID
- NCT02696512
- Run by
- International Brain Research Foundation
- People needed
- 30
- Starts
- 2016-03-01
- Expected to finish
- 2017-04-01
- Last updated by the study team
- 2016-09-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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%
Where it is running
- International Brain Research Foundation — Edison, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.