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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

April 30, 2017

Conditions
Brain Injury
Interventions
DRUG

Polypharmacy 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.

DEVICE

Median 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_SUPPLEMENT

Nutraceutical Supplementation

Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine,

OTHER

Standard of Care

Standard of Care treatment

Trial Locations (1)

08837

RECRUITING

International Brain Research Foundation, Edison

All Listed Sponsors
lead

International Brain Research Foundation

OTHER

NCT02696512 - A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness | Biotech Hunter | Biotech Hunter