Hyperbaric Oxygen for Post Concussive Syndrome | NCT03205215

Studies
Hyperbaric Oxygen for Post Concussive Syndrome

NCT03205215

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Jan 18, 2019Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Post-Concussion Syndrome

Interventions

Hyperbaric Oxygen Therapy
Waitlist Hyperbaric Oxygen Therapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jun 27, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jul 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2019

Last Update Posted Date

Jan 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Harrison, Medical Manager and Clinical Associate Professor, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.

Detailed Description

Purpose:

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (PCS).

Hypothesis:

The study hypothesis is that HBOT will decrease symptoms measured by standard measurement tools when provided to patients who have a diagnosis of PCS and are 6 months to 36 months post injury.

Study Overview:

Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level.

Participants will be selected from the post-concussive syndrome population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will be experiencing post concussive symptoms related to an injury within the last 6 to 36 months. The study will be enrolling 150 participants and will be randomized to two different treatment arms: experimental group and a waitlist group.

Each participant will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, at the end of treatment, 8 months and 14 months after treatment begins. The primary outcome will be administered at these times as well as every two weeks once treatment begins until the end of the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Treatment	Experimental	This arm will receive hyperbaric oxygen therapy once consented.	Other: Hyperbaric Oxygen Therapy
Waitlist - to be treated	Experimental	This arm will receive a hyperbaric oxygen therapy after waiting two months.	Other: Waitlist Hyperbaric Oxygen Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric Oxygen Therapy	Other	100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks	Immediate Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Rivermead Post Concussion Syndrome Questionnaire	15 questions regarding a participant's Post Concussive symptoms	Baseline, after 10, 20, 30 hyperbaric treatments, 2, 2.5, 3, 3.5, 4,4.5, 5, 5.5 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5 and 14 months post baseline,

Secondary Outcomes

Measure	Description	Time Frame
Change in the NIH Tool Box	Cognitive Assessment Cluster	Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline
Change in the Patient Health Questionnaire (PHQ-9)	Depression Assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to speak English and give informed consent.
A diagnosis of chronic PCS made by a referring physician
Time of injury between 6 and 36 months previously
Able to sit in the chamber for 120 minutes.

Exclusion Criteria:

Untreated collapsed lung (pneumothorax)
Have taken the chemotherapy drug Doxorubicin within 72 hours
Have taken the chemotherapy drug Bleomycin within 4 months
Bowel obstruction
Heart pacemaker that has not been certified as safe for exposure to 2.0 ATA
Pregnancy
Severe Chronic Obstructive Pulmonary Disease (COPD)
Participation in other PCS related studies.
Previous recent HBOT
Previous recent deep sea diving experience

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David W Harrison, MD,CCFP(EM),FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital - Hyperbaric Unit		Vancouver	British Columbia	V5Z 1M9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D038223	Post-Concussion Syndrome
D001924	Brain Concussion

Ancestor Terms

ID	Term
D016489	Head Injuries, Closed
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided