Clinical trial NCT02696512: A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Brain Injury
Keywords: Severe Disorders of Consciousness (SDOC)
Coma
Vegetative State
Minimally Conscious State
Lead sponsor: International Brain Research Foundation
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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%

Primary outcomes:
measure: Tolerance to treatment
timeFrame: Week 12
measure: Number and Frequency of side effects
timeFrame: Week 12
measure: Adverse events
timeFrame: Week 12
Secondary outcomes:
measure: coma recovery scale-revised (CRS-R)
timeFrame: Week 12
measure: disability rating scale (DRS)
timeFrame: Week 12
measure: functional assessment measure (FIM)
timeFrame: Week 12
measure: Glasgow coma scal (GCS)
timeFrame: Week 12
measure: Glasgow outcome scale-extended (GOS-E)
timeFrame: Week 12
measure: orientation log (O-LOG)
timeFrame: Week 12
measure: vegetative state (VS)
timeFrame: Week 12
measure: minimally conscious state (MCS)
timeFrame: Week 12
Other outcomes:
Locations:
city: Edison
country: United States
facility: International Brain Research Foundation
state: New Jersey
Study officials:
affiliation: IBRF
name: Philip A Defina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: