Recruiting
Phase 1
Phase 2

IBRF Disorders

Sponsor:

International Brain Research Foundation

Code:

NCT02696512

Conditions

Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Polypharmacy using FDA-approved products

Median Nerve Stimulation (MNS)

Nutraceutical Supplementation

Standard of Care

Study Details

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).

Conditions

Brain Injury

Study ID

NCT02696512

Start date

Mar, 2016

Status verified date

Aug, 2016

Completion date

Apr, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 Group 2

Standard of Care only

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.

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.

Nutraceutical Supplementation

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

Standard of Care

Standard of Care treatment

Primary outcome measure

  • Tolerance to treatment [ Time Frame: Week 12 ]
  • Number and Frequency of side effects [ Time Frame: Week 12 ]
  • Adverse events [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Philip A DeFina, Ph.D.

732-494-7600pdefina@ibrfinc.org

James Halper, MD

732-494-7600

Locations

International Brain Research Foundation

Recruiting

Edison, New Jersey, United States, 08837

Contacts

Philip Defina, PhD

732-494-7600pdefina@ibrfinc.org

Principal Investigator:

Philip Defina, PhD

More Information

Sponsor

International Brain Research Foundation

Last update posted

Sep 2, 2016

Last verified

Aug, 2016

Keywords

  • Severe Disorders of Consciousness (SDOC)
  • Coma
  • Vegetative State
  • Minimally Conscious State

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by International Brain Research Foundation on 2016-09-02.