NCT02582502

Brief Summary

The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

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
140

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable stroke

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

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

4.3 years

First QC Date

September 29, 2015

Last Update Submit

March 26, 2020

Conditions

StrokeIschemic StrokeEstablished Stroke

Keywords

Hyperbaric OxygenHBOTHyperbaric ChamberPressurized Oxygen

Outcome Measures

Primary Outcomes (1)

  • Change in the Stroke Impact Scale (SIS-16) from baseline over the duration of the study

    Pre treatment (Baseline and after waiting period is completed), During Treatment (3 weeks, 6 weeks) and Post Treatment (9 weeks post baseline, 8 months post and 14 months)

Secondary Outcomes (12)

  • National Institute of Health Stroke Scale (NIHSS)

    Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)

  • Nine hole peg board

    Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)

  • Grip Strength

    Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)

  • Berg Balance Test

    Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)

  • 6 metre walk test

    Pre treatment (Baseline and after waiting period) and Post Treatment (9 weeks post baseline, 8 months post and 14 months post)

  • +7 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

This arm will receive Hyperbaric Oxygen Therapy immediately after consent into study.

Other: Hyperbaric Oxygen

Wait list Treatment

OTHER

This arm will receive Hyperbaric Oxygen Therapy two months after consenting into study.

Other: Hyperbaric Oxygen

Interventions

Hyperbaric OxygenOTHER

The only intervention given will be 100% oxygen under hyperbaric pressure.

TreatmentWait list Treatment

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 19 and 85.
  • Able to speak English and give informed consent or have a substitute decision maker and able to assent.
  • One or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months
  • Able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes.

You may not qualify if:

  • Contraindication to HBOT (Appendix C) including:
  • 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 of unknown make and model
  • Pregnancy
  • Cigarette Smoking
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Participation in other stroke related studies.
  • Previous history stroke \> 36 months prior to study baseline

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

StrokeIschemic Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

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

    Vancouver General Hospital and 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
Principal Investigator

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 21, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)