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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine,
International Brain Research Foundation
Edison, New Jersey, United States
RECRUITINGTolerance to treatment
The percent of patients completing the treatment protocol
Time frame: Week 12
Number and Frequency of side effects
The total number and frequency of side effects experienced by patients based on observations and evaluations of the patients' clinical laboratory tests
Time frame: Week 12
Adverse events
Based on observations of the study patients and evaluations of clinical laboratory tests
Time frame: Week 12
coma recovery scale-revised (CRS-R)
Time frame: Week 12
disability rating scale (DRS)
Time frame: Week 12
functional assessment measure (FIM)
Time frame: Week 12
Glasgow coma scal (GCS)
Time frame: Week 12
Glasgow outcome scale-extended (GOS-E)
Time frame: Week 12
orientation log (O-LOG)
Time frame: Week 12
vegetative state (VS)
Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports
Time frame: Week 12
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Standard of Care treatment
minimally conscious state (MCS)
Time frame: Week 12