Brain Injury
Conditions
Keywords
Severe Disorders of Consciousness (SDOC), Coma, Vegetative State, Minimally Conscious State
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.
Interventions
DRUGPolypharmacy using FDA-approved products
Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12, Methylfolate, Rasagiline, Amantadine, Naltrexone and Levodopa/carbidopa.
DEVICEMedian Nerve Stimulation (MNS)
40 cycle/second (gamma range) asymmetric, 2 ms wavebands with 300 µs bursts at 20 milliamps bilaterally (randomized left arm and right arm sequencing algorithm) applied 20 seconds on and 40 seconds off for 8 hours per day.
DIETARY_SUPPLEMENTNutraceutical Supplementation
Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine,
OTHERStandard of Care
Standard of Care treatment
Sponsors
International Brain Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance to treatment | Week 12 | The percent of patients completing the treatment protocol |
| Number and Frequency of side effects | 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 | Week 12 | Based on observations of the study patients and evaluations of clinical laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional assessment measure (FIM) | Week 12 | — |
| Glasgow coma scal (GCS) | Week 12 | — |
| vegetative state (VS) | Week 12 | Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports |
| orientation log (O-LOG) | Week 12 | — |
| minimally conscious state (MCS) | Week 12 | — |
| Glasgow outcome scale-extended (GOS-E) | Week 12 | — |
| coma recovery scale-revised (CRS-R) | Week 12 | — |
| disability rating scale (DRS) | Week 12 | — |
Countries
United States
Contacts
Primary ContactPhilip A DeFina, Ph.D.
Backup ContactJames Halper, MD
Outcome results
None listed