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

August 31, 2016 updated by: International Brain Research Foundation

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: James Halper, MD
  • Phone Number: 732-494-7600

Study Locations

  • United States
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Recruiting
        • International Brain Research Foundation
        • Contact:
        • Principal Investigator:
          • Philip Defina, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Other: Standard of Care
Standard of Care treatment
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 Group 2
Standard of Care only
Other: Standard of Care
Standard of Care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance to treatment
Time Frame: Week 12
The percent of patients completing the treatment protocol
Week 12
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
Week 12
Adverse events
Time Frame: Week 12
Based on observations of the study patients and evaluations of clinical laboratory tests
Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Brain Research Foundation

Investigators

  • Principal Investigator: Philip A Defina, Ph.D., IBRF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBRF-01-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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