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Hyperbaric Oxygen Therapy for Post-Concussion Syndrome (HOINPCS Trial)
Phase 2
Waitlist Available
Led By Marc Basson, MD, PhD
Research Sponsored by Essentia Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TBI was caused by non-penetrating trauma
Volunteers must be 18-year-old or more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week, 13-week, 18-month
Awards & highlights
HOINPCS Trial Summary
This trial is evaluating whether hyperbaric oxygen is an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms.
Who is the study for?
Adults who've had a mild traumatic brain injury between 3 months to 5 years ago and are experiencing ongoing symptoms like headaches or dizziness. They must be able to speak English, give informed consent, follow the study plan, and provide blood samples. Excluded are pregnant women, prisoners, minors, those with severe TBIs or certain medical conditions that prevent safe hyperbaric treatment.Check my eligibility
What is being tested?
The trial is testing if breathing pure oxygen in a pressurized chamber (hyperbaric oxygen at 1.5 ATA) can help improve brain function after concussion compared to a sham (fake) treatment. Participants will be randomly assigned to one of these two treatments.See study design
What are the potential side effects?
Hyperbaric oxygen therapy may cause ear pressure-related discomforts such as barotrauma, sinus pain, temporary vision changes and fatigue. Rarely it could lead to more serious issues like lung collapse due to air pressure changes.
HOINPCS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain injury was caused by a blow to the head, not by something going through my skull.
Select...
I am 18 years old or older.
Select...
I am experiencing symptoms like headaches, dizziness, or mood/thinking problems due to a brain injury.
HOINPCS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-week, 13-week, 18-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week, 13-week, 18-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Repeatable battery for the assessment of neuropsychological status (RBANS)
Secondary outcome measures
Changes in Neurobehavioral Symptom Inventory (NSI) scores
Changes in Pittsburg Sleep Quality Index (PSQI) score
Changes in World Health Organization Quality of Life -BREF (WHOQOL-BREF) domain scores
+2 moreHOINPCS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HBO at 1.5 Atmosphere absoluteExperimental Treatment1 Intervention
Participants in this group will be exposed to hyperbaric oxygen at 1.5 atmosphere absolute (ATA) for 60 minutes per session. Each participant will complete 40 sessions, five sessions per week within 3 months from randomization
Group II: Sham control initially at 1.2 then changed to 1.0 ATAPlacebo Group1 Intervention
Participants in this group will be exposed to hyperbaric oxygen at 1.2 atmosphere absolute (ATA) during the first 5 to 7 minutes and the chamber pressure will be reduced to 1.0 ATA for the remaining 53 - 57 minutes for a total of 60 minutes per session. Each participant will complete 40 sessions, five sessions per week within 3 months from randomization
Find a Location
Who is running the clinical trial?
Essentia HealthLead Sponsor
26 Previous Clinical Trials
108,170 Total Patients Enrolled
University of North DakotaOTHER
15 Previous Clinical Trials
1,178 Total Patients Enrolled
Dakota Medical FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who work in or use hyperbaric chambers, or engage in SCUBA diving.You cannot protect your airway or need frequent suctioning.I am 18 years old or older.I have had hyperbaric oxygen treatment before.I cannot undergo hyperbaric oxygen treatments.You have been diagnosed with a serious mental health condition like schizophrenia, bipolar disorder, or dissociative disorder.I have had a serious head injury in the past.I had a mild head injury between 3 months and 5 years ago.I have a tracheostomy.My brain injury was caused by a blow to the head, not by something going through my skull.You have experienced a mild traumatic brain injury and still have symptoms that have been checked by a brain specialist.I am experiencing symptoms like headaches, dizziness, or mood/thinking problems due to a brain injury.I cannot fully participate in all required study assessments.I have had a brain injury not caused by physical trauma, like a stroke or drug-induced coma.You have a confirmed diagnosis of a learning disability.I have or might have a lymphatic system leak.I am claustrophobic and cannot enter a hyperbaric chamber.You have an implanted device that cannot be checked for safety by the manufacturer.I am unable to understand and sign the consent form by myself.I have a collapsed lung that hasn't been treated.I am under 18 years old.I can pop my ears or am willing to get a procedure to help with that.
Research Study Groups:
This trial has the following groups:- Group 1: HBO at 1.5 Atmosphere absolute
- Group 2: Sham control initially at 1.2 then changed to 1.0 ATA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been accepted into this clinical trial?
"Affirmative. The information on clinicaltrials.gov indicates that this medical study, initially posted on May 27th 2022, is actively enrolling patients. Approximately 100 participants must be recruited from a single site."
Answered by AI
Are there available slots for participants in the clinical trial?
"Affirmative. Clinicaltrials.gov reflects that this medical trial, which was published on May 27th 2022, is actively recruiting participants. Exactly 100 patients will be admitted from 1 clinical site."
Answered by AI
Is Hyperbaric oxygen therapy at 1.5 ATA certified by the FDA?
"Hyperbaric oxygen therapy at 1.5 ATA is rated a 2 because the available clinical evidence indicates that it has some safety data, yet no proof of efficacy in this Phase 2 trial."
Answered by AI
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