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

International Brain Research Foundation

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Brain Injury

Treatments: Other: Standard of Care; Drug: Polypharmacy using FDA-approved products; Device: Median Nerve Stimulation (MNS); Dietary Supplement: Nutraceutical Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02696512

IBRF-01-10

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

IBRF ACP/MCP Group 1

Experimental group

Description:

The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)

Treatment:

Dietary Supplement: Nutraceutical Supplementation

Other: Standard of Care

Device: Median Nerve Stimulation (MNS)

Drug: Polypharmacy using FDA-approved products

Standard of Care Group 2

Other group

Description:

Standard of Care only

Treatment:

Other: Standard of Care