Carbon Monoxide PoisoningHACMICENCT04118491
Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy
A study of Carbon Monoxide Poisoning and Chronic Encephalopathy, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Carbon Monoxide Poisoning, Chronic Encephalopathy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2023to 6 Jun 2023
- Phase
- Interventional
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Carbon Monoxide Poisoning, Chronic Encephalopathy
- Being tested
- hyperbaric oxygen and sham hyperbaric oxygen
- Medical subject headings
- Carbon Monoxide Poisoning, Brain Damage, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen and sham hyperbaric oxygenDevice
see arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| sham1st | Sham comparator | 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. Receives: Device: hyperbaric oxygen and sham hyperbaric oxygen |
| sham second | Active comparator | 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. Receives: Device: hyperbaric oxygen and sham hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form (36) Health Survey
is a 36-item, patient-reported survey of patient health
Measured: 4 months (after 80 treatments)
Secondary outcomes (6)
Updrs part 3 (motor function)
Unified Parkinson Disease Rating Scale
Measured: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
BARS- Brief Ataxia Rating Scale
an assessment of ataxia, 30 point scale with 0 being normal
Measured: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Fahn-Marsden Dystonia Rating Scale
an assessment of dystonia, 120 point scale with 0 being normal
Measured: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Physician assessment
an assessment of global function, this is a verbal description not a scale
Measured: prior to study, after 40 treatments and 80 treatments (0, 2 and 4 months)
The Montreal Cognitive Assessment
a brief cognitive screening tool for Mild Cognitive Impairment
Measured: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Short Form (36) Health Survey
is a 36-item, patient-reported survey of patient health
Measured: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start6 Jun 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- treating with hyperbaric oxygen therapy vs sham in a randomized crossover fashion
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Cooper, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118491
- Sponsor's protocol ID
- 0225-18-FB
- Acronym
- HACMICE
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2019
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy
- ClinicalTrials.gov ID
- NCT04118491
- Acronym / sponsor ID
- HACMICE / 0225-18-FB
- Conditions
- Carbon Monoxide Poisoning, Chronic Encephalopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 8 Oct 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- treating with hyperbaric oxygen therapy vs sham in a randomized crossover fashion
| Arm | Type | Receives |
|---|---|---|
| sham1st | Sham comparator | Device: hyperbaric oxygen and sham hyperbaric oxygen40 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. |
| sham second | Active comparator | Device: hyperbaric oxygen and sham hyperbaric oxygeniii. 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| hyperbaric oxygen and sham hyperbaric oxygensee arm descriptions | Device | sham second, sham1st |
Primary outcome
Short Form (36) Health Survey
Time frame: 4 months (after 80 treatments)
is a 36-item, patient-reported survey of patient health
6 secondary outcomes
Updrs part 3 (motor function)
Time frame: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
BARS- Brief Ataxia Rating Scale
Time frame: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Fahn-Marsden Dystonia Rating Scale
Time frame: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Physician assessment
Time frame: prior to study, after 40 treatments and 80 treatments (0, 2 and 4 months)
The Montreal Cognitive Assessment
Time frame: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Short Form (36) Health Survey
Time frame: 0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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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.
Jeffrey Cooper, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study of Carbon Monoxide Poisoning and Chronic Encephalopathy, run by University of Nebraska.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form (36) Health Survey (time frame: 4 months (after 80 treatments)). 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 3 Sep 2024.