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

Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02696512
• Other study ID #: IBRF-01-10
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 19, 2015
• Last updated: August 31, 2016
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: International Brain Research Foundation
• Contact: Philip A DeFina, Ph.D.
• Phone: 732-494-7600
• Email: pdefina[@]ibrfinc.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Consciousness Disorders

Intervention

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.

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.

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

Other:
• Standard of Care
Standard of Care treatment

Locations

Country	Name	City	State
United States	International Brain Research Foundation	Edison	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
International Brain Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance to treatment	The percent of patients completing the treatment protocol	Week 12	Yes
Primary	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	Yes
Primary	Adverse events	Based on observations of the study patients and evaluations of clinical laboratory tests	Week 12	Yes
Secondary	coma recovery scale-revised (CRS-R)		Week 12	No
Secondary	disability rating scale (DRS)		Week 12	No
Secondary	functional assessment measure (FIM)		Week 12	No
Secondary	Glasgow coma scal (GCS)		Week 12	No
Secondary	Glasgow outcome scale-extended (GOS-E)		Week 12	No
Secondary	orientation log (O-LOG)		Week 12	No
Secondary	vegetative state (VS)	Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports	Week 12	No
Secondary	minimally conscious state (MCS)		Week 12	No