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

NCT ID: NCT02696512

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-04-30

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.

Conditions

Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Polypharmacy using FDA-approved products

Intervention Type: DRUG

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.

Median Nerve Stimulation (MNS)

Intervention Type: DEVICE

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.

Nutraceutical Supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Standard of Care

Intervention Type: OTHER

Standard of Care treatment

Standard of Care Group 2

Standard of Care only

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Standard of Care treatment

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Nutraceutical Supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Standard of Care

Standard of Care treatment

Intervention Type: OTHER

Other Intervention Names

Minocycline, Lamotrigine, Flumazenil, and others; Empi PV300 TENS; Acidophilus, Alpha-Lipoic Acid, and others

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Brain Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip A Defina, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

IBRF

Locations

International Brain Research Foundation

Edison, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Philip A DeFina, Ph.D.

Role: CONTACT

pdefina@ibrfinc.org

732-494-7600

James Halper, MD

Role: CONTACT

732-494-7600

Facility Contacts

Philip Defina, PhD

Role: primary

pdefina@ibrfinc.org

732-494-7600

Other Identifiers

IBRF-01-10

Identifier Type: -

Identifier Source: org_study_id