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

Primary Purpose

Brain Injury

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Polypharmacy using FDA-approved products

Median Nerve Stimulation (MNS)

Nutraceutical Supplementation

Standard of Care

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Severe Disorders of Consciousness (SDOC), Coma, Vegetative State, Minimally Conscious State

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

International Brain Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IBRF ACP/MCP Group 1

Standard of Care Group 2

Arm Description

The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)

Standard of Care only

Outcomes

Primary Outcome Measures

Tolerance to treatment

The percent of patients completing the treatment protocol

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

Adverse events

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

Secondary Outcome Measures

coma recovery scale-revised (CRS-R)

disability rating scale (DRS)

functional assessment measure (FIM)

Glasgow coma scal (GCS)

Glasgow outcome scale-extended (GOS-E)

orientation log (O-LOG)

vegetative state (VS)

Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports

minimally conscious state (MCS)

Full Information

NCT ID

NCT02696512

First Posted

November 19, 2015

Last Updated

August 31, 2016

Sponsor

International Brain Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02696512

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Brain Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IBRF ACP/MCP Group 1

Arm Type

Experimental

Arm Description

The Treatment group will be receiving a combination of pharmaceuticals (polypharmacy using FDA-approved products) and nutraceuticals (Nutraceutical supplementation) and median nerve stimulation (MNS)

Arm Title

Standard of Care Group 2

Arm Type

Other

Arm Description

Standard of Care only

Intervention Type

Drug

Intervention Name(s)

Polypharmacy using FDA-approved products

Other Intervention Name(s)

Minocycline, Lamotrigine, Flumazenil, and others

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Median Nerve Stimulation (MNS)

Other Intervention Name(s)

Empi PV300 TENS

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutraceutical Supplementation

Other Intervention Name(s)

Acidophilus, Alpha-Lipoic Acid, and others

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Standard of Care treatment

Primary Outcome Measure Information:

Title

Tolerance to treatment

Description

The percent of patients completing the treatment protocol

Time Frame

Week 12

Title

Number and Frequency of side effects

Description

The total number and frequency of side effects experienced by patients based on observations and evaluations of the patients' clinical laboratory tests

Time Frame

Week 12

Title

Adverse events

Description

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

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

coma recovery scale-revised (CRS-R)

Time Frame

Week 12

Title

disability rating scale (DRS)

Time Frame

Week 12

Title

functional assessment measure (FIM)

Time Frame

Week 12

Title

Glasgow coma scal (GCS)

Time Frame

Week 12

Title

Glasgow outcome scale-extended (GOS-E)

Time Frame

Week 12

Title

orientation log (O-LOG)

Time Frame

Week 12

Title

vegetative state (VS)

Description

Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports

Time Frame

Week 12

Title

minimally conscious state (MCS)

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philip A DeFina, Ph.D.

Phone

732-494-7600

pdefina@ibrfinc.org

First Name & Middle Initial & Last Name or Official Title & Degree

James Halper, MD

Phone

732-494-7600

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip A Defina, Ph.D.

Organizational Affiliation

IBRF

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Brain Research Foundation

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08837

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philip Defina, PhD

Phone

732-494-7600

pdefina@ibrfinc.org

First Name & Middle Initial & Last Name & Degree

Philip Defina, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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