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

NCT01985100 | Withdrawn

• 1 other identifier: StLukesMO # 2013.021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

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

  2 weeks after treatment with Hyperbaric Oxygen

Secondary Outcomes (1)

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

  2 weeks after completion of hyperbaric oxygen therapy

Study Arms (1)

single group

EXPERIMENTAL

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

Interventions

hyperbaric oxygen chamber OTHER

single group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• John Davidson: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John D Davidson, MD

  St. Luke's Hospital St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 15, 2013
• Study Start: November 21, 2013
• Primary Completion: September 27, 2014
• Study Completion: September 27, 2014
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)