Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05173818
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-12-13
Brief Title:
Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms
Sponsor:
Essentia Health
Organization:
Essentia Health
Study Overview
Official Title:
Effect of Hyperbaric Oxygen on Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOINPCS
Brief Summary:
Persistent post-concussive symptoms PPCS are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82 based on timing of assessment diagnostic criteria or population under study
Examples of persistent post-concussion symptoms include balance problems headaches fatigue poor concentration forgetfulness anxiety irritability and sleep disturbance Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury
The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms
The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS
Examples of persistent post-concussion symptoms include balance problems headaches fatigue poor concentration forgetfulness anxiety irritability and sleep disturbance Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury
The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms
The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS
Detailed Description:
This is a parallel randomized double-blinded and sham-controlled study A total of 100 subjects will be randomly assigned to either an intervention arm 50 participants exposed to 999 oxygen at 15 atmosphere absolute for 60 minutes over 40 treatments or sham-treatment arm 50 participants exposed to oxygen and pressure composition equivalent to breathing atmospheric air for 60 minutes over 40 treatments
This study is designed to determine whether hyperbaric oxygen improves neuropsychological status and ameliorates symptoms in adults with persistent post-concussive symptoms PPCS following mild traumatic brain injury It recruits from either military or civilian population uses a validated screening tool - Repeatable battery for the assessment of neuropsychological status RBANS- used in dementia and other forms of brain injury not used hitherto in previous randomized control trial that investigated the effectiveness of hyperbaric oxygen in the management of PPCS It also includes a concssuon biomarker as an objective secondary endpoint
The study is based on repeated measure design The study will describe and track changes in the outcomes of interest over time and examine associations between measures within each participant and across certain participant characteristics
This study is designed to determine whether hyperbaric oxygen improves neuropsychological status and ameliorates symptoms in adults with persistent post-concussive symptoms PPCS following mild traumatic brain injury It recruits from either military or civilian population uses a validated screening tool - Repeatable battery for the assessment of neuropsychological status RBANS- used in dementia and other forms of brain injury not used hitherto in previous randomized control trial that investigated the effectiveness of hyperbaric oxygen in the management of PPCS It also includes a concssuon biomarker as an objective secondary endpoint
The study is based on repeated measure design The study will describe and track changes in the outcomes of interest over time and examine associations between measures within each participant and across certain participant characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None