A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Brain Research Foundation
• Treatments: Flumazenil; Lamotrigine; Minocycline; Thioctic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%