NCT03205215

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

June 27, 2017

Last Update Submit

January 16, 2019

Conditions

Post-Concussion Syndrome

Keywords

Hyperbaric oxygenPressurized oxygenConcussionPost concussive syndromeOxygen therapy

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Change in the NIH Tool Box

    Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline

  • Change in the Patient Health Questionnaire (PHQ-9)

    Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline

  • Change in the Short Form Health Survey (SF-36)

    Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline

  • Change in the Quality of Life After Brain Injury (QOLIBRI)

    Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline

  • Change in the WHO Disability Assessment Schedule (WHODAS 2.0)

    Baseline, 2 months post baseline, 8 months post baseline, 14 months post baseline

Study Arms (2)

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

Hyperbaric Oxygen TherapyOTHER

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Immediate Treatment
Waitlist Hyperbaric Oxygen TherapyOTHER

100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Waitlist - to be treated

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital - Hyperbaric Unit

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Post-Concussion SyndromeBrain Concussion

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Head Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • David W Harrison, MD,CCFP(EM),FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Manager and Clinical Associate Professor

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 2, 2017

Study Start

September 1, 2018

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)