Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy

NCT04118491 | Withdrawn DMC FDA Device

• 1 other identifier: 0225-18-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carbon Monoxide Poisoning; Chronic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Short Form (36) Health Survey

  is a 36-item, patient-reported survey of patient health

  4 months (after 80 treatments)

Secondary Outcomes (6)

• Updrs part 3 (motor function)

  0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)

• BARS- Brief Ataxia Rating Scale

  0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)

• Fahn-Marsden Dystonia Rating Scale

  0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)

• Physician assessment

  prior to study, after 40 treatments and 80 treatments (0, 2 and 4 months)

• The Montreal Cognitive Assessment

  0, 2 and 4 months: (prior to study, after 40 treatments and 80 treatments)

Study Arms (2)

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.

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.

Device: hyperbaric oxygen and sham hyperbaric oxygen

Interventions

hyperbaric oxygen and sham hyperbaric oxygen DEVICE

see arm descriptions

sham second; sham1st

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Carbon Monoxide Poisoning; Brain Damage, Chronic

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Cooper, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: treating with hyperbaric oxygen therapy vs sham in a randomized crossover fashion

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: October 8, 2019
• Study Start: June 6, 2023
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: September 3, 2024

Record last verified: 2024-08