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

NCT02696512 | Unknown Phase 1

• 1 other identifier: IBRF-01-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Tolerance to treatment

  The percent of patients completing the treatment protocol

  Week 12

• Number and Frequency of side effects

  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

  Based on observations of the study patients and evaluations of clinical laboratory tests

  Week 12

Secondary Outcomes (8)

• 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

Study Arms (2)

IBRF ACP/MCP Group 1

EXPERIMENTAL

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; Device: Median Nerve Stimulation (MNS); Dietary Supplement: Nutraceutical Supplementation; Other: Standard of Care

Standard of Care Group 2

OTHER

Standard of Care only

Other: Standard of Care

Interventions

Polypharmacy using FDA-approved products 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.

Also known as: Minocycline, Lamotrigine, Flumazenil, and others

IBRF ACP/MCP Group 1

Median Nerve Stimulation (MNS) 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.

Also known as: Empi PV300 TENS

IBRF ACP/MCP Group 1

Nutraceutical Supplementation DIETARY_SUPPLEMENT

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

Also known as: Acidophilus, Alpha-Lipoic Acid, and others

IBRF ACP/MCP Group 1

Standard of Care OTHER

Standard of Care treatment

IBRF ACP/MCP Group 1; Standard of Care Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• International Brain Research Foundation: lead

Study Sites (1)

International Brain Research Foundation

Edison, New Jersey, 08837, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Coma; Persistent Vegetative State

Interventions

Minocycline; Lamotrigine; Flumazenil; Lacteol; Thioctic Acid; Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Philip A Defina, Ph.D.

  IBRF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip A DeFina, Ph.D.

CONTACT

732-494-7600; pdefina@ibrfinc.org

James Halper, MD

CONTACT

732-494-7600

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: March 2, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)