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Trial record 10 of 11 for:    lipoic acid ms

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

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ClinicalTrials.gov Identifier: NCT02696512
Recruitment Status : Unknown
Verified August 2016 by International Brain Research Foundation.
Recruitment status was:  Recruiting
First Posted : March 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
International Brain Research Foundation

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).

Condition or disease Intervention/treatment Phase
Brain Injury Drug: Polypharmacy using FDA-approved products Device: Median Nerve Stimulation (MNS) Dietary Supplement: Nutraceutical Supplementation Other: Standard of Care Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

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)
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 Name: 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 Name: 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 Name: Acidophilus, Alpha-Lipoic Acid, and others

Other: Standard of Care
Standard of Care treatment

Standard of Care Group 2
Standard of Care only
Other: Standard of Care
Standard of Care treatment




Primary Outcome Measures :
  1. Tolerance to treatment [ Time Frame: Week 12 ]
    The percent of patients completing the treatment protocol

  2. 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

  3. Adverse events [ Time Frame: Week 12 ]
    Based on observations of the study patients and evaluations of clinical laboratory tests


Secondary Outcome Measures :
  1. coma recovery scale-revised (CRS-R) [ Time Frame: Week 12 ]
  2. disability rating scale (DRS) [ Time Frame: Week 12 ]
  3. functional assessment measure (FIM) [ Time Frame: Week 12 ]
  4. Glasgow coma scal (GCS) [ Time Frame: Week 12 ]
  5. Glasgow outcome scale-extended (GOS-E) [ Time Frame: Week 12 ]
  6. orientation log (O-LOG) [ Time Frame: Week 12 ]
  7. vegetative state (VS) [ Time Frame: Week 12 ]
    Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports

  8. minimally conscious state (MCS) [ Time Frame: Week 12 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696512


Contacts
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Contact: Philip A DeFina, Ph.D. 732-494-7600 pdefina@ibrfinc.org
Contact: James Halper, MD 732-494-7600

Locations
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United States, New Jersey
International Brain Research Foundation Recruiting
Edison, New Jersey, United States, 08837
Contact: Philip Defina, PhD    732-494-7600    pdefina@ibrfinc.org   
Principal Investigator: Philip Defina, PhD         
Sponsors and Collaborators
International Brain Research Foundation
Investigators
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Principal Investigator: Philip A Defina, Ph.D. IBRF

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Responsible Party: International Brain Research Foundation
ClinicalTrials.gov Identifier: NCT02696512     History of Changes
Other Study ID Numbers: IBRF-01-10
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by International Brain Research Foundation:
Severe Disorders of Consciousness (SDOC)
Coma
Vegetative State
Minimally Conscious State

Additional relevant MeSH terms:
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Thioctic Acid
Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Minocycline
Lamotrigine
Flumazenil
Anti-Bacterial Agents
Anti-Infective Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers