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

Sponsor

International Brain Research Foundation (Other)

Overall Status

Unknown status

CT.gov ID

NCT02696512

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Injury	Drug: Polypharmacy using FDA-approved products Device: Median Nerve Stimulation (MNS) Dietary Supplement: Nutraceutical Supplementation Other: Standard of Care	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBRF ACP/MCP Group 1 The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)	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. Other Names: Minocycline, Lamotrigine, Flumazenil, and others 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. Other Names: Empi PV300 TENS Dietary Supplement: Nutraceutical Supplementation Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine, Other Names: Acidophilus, Alpha-Lipoic Acid, and others Other: Standard of Care Standard of Care treatment
Other: Standard of Care Group 2 Standard of Care only	Other: Standard of Care Standard of Care treatment

Arm

Intervention/Treatment

Experimental: IBRF ACP/MCP Group 1

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

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.

Other Names:

Minocycline, Lamotrigine, Flumazenil, and others

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.

Other Names:

Empi PV300 TENS

Dietary Supplement: Nutraceutical Supplementation

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

Other Names:

Acidophilus, Alpha-Lipoic Acid, and others

Other: Standard of Care

Standard of Care treatment

Other: Standard of Care Group 2

Standard of Care only

Other: Standard of Care

Standard of Care treatment

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

coma recovery scale-revised (CRS-R) [Week 12]
disability rating scale (DRS) [Week 12]
functional assessment measure (FIM) [Week 12]
Glasgow coma scal (GCS) [Week 12]
Glasgow outcome scale-extended (GOS-E) [Week 12]
orientation log (O-LOG) [Week 12]
vegetative state (VS) [Week 12]
Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports
minimally conscious state (MCS) [Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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%