Brain InjuryPhase 1/2NCT02696512
A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness
A Phase 1/2 study testing Polypharmacy using FDA-approved products, Median Nerve Stimulation (MNS) and Nutraceutical Supplementation in people with Brain Injury, run by International Brain Research Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Polypharmacy using FDA-approved products, Median Nerve Stimulation (MNS) and Nutraceutical Supplementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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%
Trial locations and contacts
1 site in 1 country.
James Halper, MD contact
United States1 site, 1 recruiting
- Recruiting
International Brain Research Foundation
Edison, New Jersey, 08837
Philip Defina, PhD, 732-494-7600, pdefina@ibrfinc.org
Philip Defina, PhD
About this study
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
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).
Read the 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.
- Conditions
- Brain Injury
- Being tested
- Polypharmacy using FDA-approved products, Median Nerve Stimulation (MNS), Nutraceutical Supplementation, Standard of Care
- Keywords
- Severe Disorders of Consciousness (SDOC), Coma, Vegetative State, Minimally Conscious State
- Medical subject headings
- Brain Injuries, Consciousness Disorders, Coma, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypharmacy using FDA-approved productsDrug
Also called Minocycline, Lamotrigine, Flumazenil, and others
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)Device
Also called Empi PV300 TENS
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 SupplementationDietary supplement
Also called Acidophilus, Alpha-Lipoic Acid, and others
Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine,
Standard of CareOther
Standard of Care treatment
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to treatment
The percent of patients completing the treatment protocol
Measured: 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
Measured: Week 12
Adverse events
Based on observations of the study patients and evaluations of clinical laboratory tests
Measured: Week 12
Secondary outcomes (8)
coma recovery scale-revised (CRS-R)
Measured: Week 12
disability rating scale (DRS)
Measured: Week 12
functional assessment measure (FIM)
Measured: Week 12
Glasgow coma scal (GCS)
Measured: Week 12
Glasgow outcome scale-extended (GOS-E)
Measured: Week 12
orientation log (O-LOG)
Measured: Week 12
vegetative state (VS)
Clinical diagnosis (, minimally conscious state; MCS, emerged) using criteria from the Mohonk Reports
Measured: Week 12
minimally conscious state (MCS)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Brain Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip A Defina, Ph.D., Principal investigator, IBRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696512
- Sponsor's protocol ID
- IBRF-01-10
- Status last verified
- Aug 2016
- First submitted
- 19 Nov 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02696512
- Acronym / sponsor ID
- IBRF-01-10
- Conditions
- Brain Injury
- Keywords
- Severe Disorders of Consciousness (SDOC), Coma, Vegetative State, Minimally Conscious State
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- International Brain Research FoundationUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBRF ACP/MCP Group 1 | Experimental | Drug: Polypharmacy using FDA-approved products, Device: Median Nerve Stimulation (MNS), Dietary Supplement: Nutraceutical Supplementation, Other: Standard of CareThe 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 Group 2 | Other | Other: Standard of CareStandard of Care only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypharmacy using FDA-approved productsAlso: Minocycline, Lamotrigine, Flumazenil, and othersBattery 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. | Drug | IBRF ACP/MCP Group 1 |
| Median Nerve Stimulation (MNS)Also: Empi PV300 TENS40 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. | Device | IBRF ACP/MCP Group 1 |
| Nutraceutical SupplementationAlso: Acidophilus, Alpha-Lipoic Acid, and othersBattery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine, | Dietary supplement | IBRF ACP/MCP Group 1 |
| Standard of CareStandard of Care treatment | Other | IBRF ACP/MCP Group 1, Standard of Care Group 2 |
Primary outcome
Tolerance to treatment
Time frame: Week 12
The percent of patients completing the treatment protocol
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
Adverse events
Time frame: Week 12
Based on observations of the study patients and evaluations of clinical laboratory tests
8 secondary outcomes
coma recovery scale-revised (CRS-R)
Time frame: Week 12
disability rating scale (DRS)
Time frame: Week 12
functional assessment measure (FIM)
Time frame: Week 12
Glasgow coma scal (GCS)
Time frame: Week 12
Glasgow outcome scale-extended (GOS-E)
Time frame: Week 12
orientation log (O-LOG)
Time frame: Week 12
vegetative state (VS)
Time frame: Week 12
minimally conscious state (MCS)
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Halper, MD contact
Philip A Defina, Ph.D. principal investigator
IBRF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polypharmacy using FDA-approved products, Median Nerve Stimulation (MNS) and Nutraceutical Supplementation in people with Brain Injury, run by International Brain Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip A DeFina, Ph.D. (732-494-7600, pdefina@ibrfinc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance to treatment (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.