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Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy (HACMICE)

Primary Purpose

Carbon Monoxide Poisoning, Chronic Encephalopathy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyperbaric oxygen and sham hyperbaric oxygen
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CO induced neurological or cognitive sequelae assessed as at least mild (e.g. UPDRS part 3 (motor)>15).
  • chronicity- signs or symptoms present for greater than one year after exposure.

Exclusion Criteria:

  • age >90 or less than 10 years
  • other morbidities which may contribute to chronic neurocognitive deficits (such as traumatic brain injury, poisoning by other toxins, other neurodegenerative diseases)
  • pregnancy (if a subject becomes pregnant she will be removed from the study)
  • routine contraindications to hyperbaric oxygen

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    sham1st

    sham second

    Arm Description

    40 sham HBO2 treatments (air at near normal pressure (1.2 ATA)). Treatments will be done once daily for 2 hours, Monday through Friday. The second block will be treated similarly except that they will receive sham treatments in the first block and oxygen treatments in the second block.

    iii. We will divide the subjects into two groups of five. One group will receive 40 Hyperbaric Oxygen (HBO2) treatments (100% oxygen at twice normal air pressure (2 ATA)) followed by 40 sham HBO2 treatments (air at near normal pressure (1.2 ATA)). Treatments will be done once daily for 2 hours, Monday through Friday. The second block will be treated similarly except that they will receive sham treatments in the first block and oxygen treatments in the second block. iv. Neurological and psychologic assessments will be done prior to starting treatments, after the first block of 40 and again after the second block of 40.

    Outcomes

    Primary Outcome Measures

    Short Form (36) Health Survey
    is a 36-item, patient-reported survey of patient health

    Secondary Outcome Measures

    Updrs part 3 (motor function)
    Unified Parkinson Disease Rating Scale
    BARS- Brief Ataxia Rating Scale
    an assessment of ataxia, 30 point scale with 0 being normal
    Fahn-Marsden Dystonia Rating Scale
    an assessment of dystonia, 120 point scale with 0 being normal
    Physician assessment
    an assessment of global function, this is a verbal description not a scale
    The Montreal Cognitive Assessment
    a brief cognitive screening tool for Mild Cognitive Impairment
    Short Form (36) Health Survey
    is a 36-item, patient-reported survey of patient health

    Full Information

    First Posted
    July 26, 2019
    Last Updated
    August 18, 2023
    Sponsor
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04118491
    Brief Title
    Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy
    Acronym
    HACMICE
    Official Title
    Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no funding
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    June 6, 2023 (Actual)
    Study Completion Date
    June 6, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In some patients, a few days or weeks after recovery from carbon monoxide poisoning, new symptoms develop. These can affect mood, ability to think or remember clearly, and movements. Some people develop movement problems that are similar to Parkinson's disease. This damage to brain tissue is called "encephalopathy," and this study will look at the effect of pressurized oxygen therapy on long term, or chronic, encephalopathy.
    Detailed Description
    Carbon monoxide (CO) poisoning is a leading cause of unintentional poisoning deaths in the United States. After a period of apparent recovery, survivors of acute CO-poisoning can develop a potentially permanent neurologic deterioration (DNS). DNS is a rare, poorly known encephalopathy with a 25-50% prevalence among severely poisoned CO-poisoned patients. Its symptoms and signs range from subtle abnormalities to severe dementia, Parkinsonism, gait disturbances, mutism, and incontinence. Recovery from delayed neuropsychiatric syndrome occurs in 50-75% of patients within 1 year. However, this leaves 25-50% permanently impaired. Hyperbaric oxygen therapy (HBO2) is useful after acute poisoning to reduce the chance of developing DNS. However, appropriate therapy for DNS is widely debated; particularly, the role of hyperbaric oxygen therapy (HBO2) after DNS has developed is controversial. This study proposes to ascertain whether hyperbaric oxygen is efficacious in the treatment of chronic DNS brain injury from carbon monoxide (CO) poisoning. Ten participants suffering from DNS for longer than one year will be recruited to the study, which will be prospective, blinded, sham-controlled and crossover in design. Participants will be divided into two groups of five. One group will receive 40 HBO2 treatments [100% oxygen at twice normal air pressure (2 ATA)] followed by 40 sham HBO2 treatments [air at near normal pressure (1.2 ATA)]. Treatments will be done once daily for 2 hours, Monday through Friday. Neurological and psychologic assessments will be done prior to starting treatments, after each group of 40 treatments. The second group will be treated similarly except that they will receive sham treatments in the first and oxygen treatments second. In this manner, all participants will act as both experimental and control subject and will receive treatment which we believe is therapeutic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carbon Monoxide Poisoning, Chronic Encephalopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    treating with hyperbaric oxygen therapy vs sham in a randomized crossover fashion
    Masking
    Participant
    Masking Description
    sham control- sham HBO2 treatments (air at near normal pressure (1.2 ATA)). Treatments will be done once daily for 2 hours, Monday through Friday.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sham1st
    Arm Type
    Sham Comparator
    Arm Description
    40 sham HBO2 treatments (air at near normal pressure (1.2 ATA)). Treatments will be done once daily for 2 hours, Monday through Friday. The second block will be treated similarly except that they will receive sham treatments in the first block and oxygen treatments in the second block.
    Arm Title
    sham second
    Arm Type
    Active Comparator
    Arm Description
    iii. We will divide the subjects into two groups of five. One group will receive 40 Hyperbaric Oxygen (HBO2) treatments (100% oxygen at twice normal air pressure (2 ATA)) followed by 40 sham HBO2 treatments (air at near normal pressure (1.2 ATA)). Treatments will be done once daily for 2 hours, Monday through Friday. The second block will be treated similarly except that they will receive sham treatments in the first block and oxygen treatments in the second block. iv. Neurological and psychologic assessments will be done prior to starting treatments, after the first block of 40 and again after the second block of 40.
    Intervention Type
    Device
    Intervention Name(s)
    hyperbaric oxygen and sham hyperbaric oxygen
    Intervention Description
    see arm descriptions
    Primary Outcome Measure Information:
    Title
    Short Form (36) Health Survey
    Description
    is a 36-item, patient-reported survey of patient health
    Time Frame
    4 months (after 80 treatments)
    Secondary Outcome Measure Information:
    Title
    Updrs part 3 (motor function)
    Description
    Unified Parkinson Disease Rating Scale
    Time Frame
    0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
    Title
    BARS- Brief Ataxia Rating Scale
    Description
    an assessment of ataxia, 30 point scale with 0 being normal
    Time Frame
    0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
    Title
    Fahn-Marsden Dystonia Rating Scale
    Description
    an assessment of dystonia, 120 point scale with 0 being normal
    Time Frame
    0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
    Title
    Physician assessment
    Description
    an assessment of global function, this is a verbal description not a scale
    Time Frame
    prior to study, after 40 treatments and 80 treatments (0, 2 and 4 months)
    Title
    The Montreal Cognitive Assessment
    Description
    a brief cognitive screening tool for Mild Cognitive Impairment
    Time Frame
    0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
    Title
    Short Form (36) Health Survey
    Description
    is a 36-item, patient-reported survey of patient health
    Time Frame
    0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CO induced neurological or cognitive sequelae assessed as at least mild (e.g. UPDRS part 3 (motor)>15). chronicity- signs or symptoms present for greater than one year after exposure. Exclusion Criteria: age >90 or less than 10 years other morbidities which may contribute to chronic neurocognitive deficits (such as traumatic brain injury, poisoning by other toxins, other neurodegenerative diseases) pregnancy (if a subject becomes pregnant she will be removed from the study) routine contraindications to hyperbaric oxygen
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey Cooper, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy

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