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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02696512
Recruitment Status : Unknown
Verified August 2016 by International Brain Research Foundation.
Recruitment status was:  Recruiting
First Posted : March 2, 2016
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):
International Brain Research Foundation

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

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 Name: 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 Name: 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 Name: Acidophilus, Alpha-Lipoic Acid, and others

Other: Standard of Care
Standard of Care treatment

Standard of Care Group 2
Standard of Care only
Other: Standard of Care
Standard of Care treatment

Primary Outcome Measures :
  1. Tolerance to treatment [ Time Frame: Week 12 ]
    The percent of patients completing the treatment protocol

  2. Number and Frequency of side effects [ Time Frame: Week 12 ]
    The total number and frequency of side effects experienced by patients based on observations and evaluations of the patients' clinical laboratory tests

  3. Adverse events [ Time Frame: Week 12 ]
    Based on observations of the study patients and evaluations of clinical laboratory tests

Secondary Outcome Measures :
  1. coma recovery scale-revised (CRS-R) [ Time Frame: Week 12 ]
  2. disability rating scale (DRS) [ Time Frame: Week 12 ]
  3. functional assessment measure (FIM) [ Time Frame: Week 12 ]
  4. Glasgow coma scal (GCS) [ Time Frame: Week 12 ]
  5. Glasgow outcome scale-extended (GOS-E) [ Time Frame: Week 12 ]
  6. orientation log (O-LOG) [ Time Frame: Week 12 ]
  7. vegetative state (VS) [ Time Frame: Week 12 ]
    Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports

  8. minimally conscious state (MCS) [ Time Frame: Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02696512

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Contact: Philip A DeFina, Ph.D. 732-494-7600
Contact: James Halper, MD 732-494-7600

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United States, New Jersey
International Brain Research Foundation Recruiting
Edison, New Jersey, United States, 08837
Contact: Philip Defina, PhD    732-494-7600   
Principal Investigator: Philip Defina, PhD         
Sponsors and Collaborators
International Brain Research Foundation
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Principal Investigator: Philip A Defina, Ph.D. IBRF

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Responsible Party: International Brain Research Foundation Identifier: NCT02696512    
Other Study ID Numbers: IBRF-01-10
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by International Brain Research Foundation:
Severe Disorders of Consciousness (SDOC)
Vegetative State
Minimally Conscious State
Additional relevant MeSH terms:
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Thioctic Acid
Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anti-Bacterial Agents
Anti-Infective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers