The Use of Hyperbaric Oxygen to Increase the Blood Supply in the Injured, But Still Alive Tissue, Around an Old Stroke (HBO)

Hyperbaric Oxygen in the Reduction of Post Stroke Ischemic Penumbra

To confirm or refute recently published data regarding the reduction in post-stroke ischemic penumbra, that used SPECT/CT, by using the more precise tools of PET/MRI.

Study Overview

• Status: Withdrawn
• Conditions: Ischemic Cerebrovascular Accident
• Intervention / Treatment: Other: hyperbaric oxygen chamber

Detailed Description

Most patients who suffer an acute ischemic stroke improve over the immediately ensuing 30-90 days. However, many patients do not improve beyond this initial period in spite of continued intensive physical therapy and supportive care. A prospective, randomized trial of the use of hyperbaric oxygen treatments in 59 such patients was published in January 2012. That study which used 40 hyperbaric oxygen treatments, indicated significant clinical neurological improvement in residual motor deficit in patients who had sustained a stroke over a year previously. An increase in brain activity in the region immediately surrounding their stroke (penumbra) was reported on the basis of SPECT studies. Regions of live cells were determined by CT. Because SPECT is primarily a measure of perfusion and not metabolic activity and CT is a poor measure of cell life, the investigators plan to assess areas of physiologic/anatomic mismatch in similar patients following hyperbaric oxygen treatment by the use of the more appropriate and precise tools, PET and MRI.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• person must have sustained an acute ischemic stroke 6-12 months prior to enrollment, exhibited clinical improvement during the initial 30-90 days post stroke, exhibited no further improvement for at least 1 month in spite of continued supportive care and physical therapy, must have at least one residual measurable motor deficit.

Exclusion Criteria:

Smoking, Contraindications to an MRI e.g. pacemaker, Contraindications to hyperbaric oxygen treatment e.g. emphysema, claustrophobia. seizure disorder, Inability to tolerate pressurization e.g. Eustachian tube dysfunction, other uncontrolled co-morbidities e.g. diabetes, hypertension, thyroid disorders, renal or hepatic dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: single group; single group of 6 patients will be treated with hyperbaric oxygen at 2 atmospheres absolute (ATA) for 90 minutes 5 days per week for 4 weeks (20 treatments) to see if the previously reported increase in cell metabolism following such treatment can be better documented by the more sensitive and precise method for assessing this, i.e. PET/MRI, than the previously reported SPECT/CT method

Other: hyperbaric oxygen chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in cellular metabolic activity in ischemic post stroke-penumbra PET scans	2 weeks after treatment with Hyperbaric Oxygen

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the motor function deficit post-stroke by Physical Therapists' measurements of motor strength	2 weeks after completion of hyperbaric oxygen therapy

Collaborators and Investigators

• Sponsor: John Davidson
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: John D Davidson, MD, St. Luke's Hospital St. Louis

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2013
• Primary Completion (Actual): September 27, 2014
• Study Completion (Actual): September 27, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: StLukesMO # 2013.021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO