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

Primary Purpose

Ischemic Cerebrovascular Accident

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hyperbaric oxygen chamber
Sponsored by
John Davidson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cerebrovascular Accident

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single group

Arm Description

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

Outcomes

Primary Outcome Measures

Increase in cellular metabolic activity in ischemic post stroke-penumbra PET scans

Secondary Outcome Measures

Change in the motor function deficit post-stroke by Physical Therapists' measurements of motor strength

Full Information

First Posted
November 7, 2013
Last Updated
October 25, 2017
Sponsor
John Davidson
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01985100
Brief Title
The Use of Hyperbaric Oxygen to Increase the Blood Supply in the Injured, But Still Alive Tissue, Around an Old Stroke
Acronym
HBO
Official Title
Hyperbaric Oxygen in the Reduction of Post Stroke Ischemic Penumbra
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit any patients that fulfilled the narrow enrollment requirements
Study Start Date
November 21, 2013 (Actual)
Primary Completion Date
September 27, 2014 (Actual)
Study Completion Date
September 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Davidson
Collaborators
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
hyperbaric oxygen chamber
Primary Outcome Measure Information:
Title
Increase in cellular metabolic activity in ischemic post stroke-penumbra PET scans
Time Frame
2 weeks after treatment with Hyperbaric Oxygen
Secondary Outcome Measure Information:
Title
Change in the motor function deficit post-stroke by Physical Therapists' measurements of motor strength
Time Frame
2 weeks after completion of hyperbaric oxygen therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Davidson, MD
Organizational Affiliation
St. Luke's Hospital St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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