Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury Clinical Trial

Official title:

Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00594503
• Other study ID #: LSU IRB #6625
• Status: Recruiting
• Phase: Phase 1
• First received: January 3, 2008
• Last updated: April 16, 2017
• Start date: January 2007
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Paul G Harch, M.D.
• Phone: 504-309-4948
• Email: paulharchmd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

Description:

The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adults or children with traumatic brain injury at least one year old

Exclusion Criteria:

Related Conditions & MeSH terms

• Brain Injuries
• Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Hyperbaric oxygen therapy
Total body exposure to increased atmospheric pressure oxygen

Locations

Country	Name	City	State
United States	Family Physicians Center	Marrero	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Paul G. Harch, M.D.	Harch Hyperbaric Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPECT brain imaging	Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy	After completion of HBOT
Secondary	Clinical history and physical exam		After completion of HBOT
Secondary	Cognitive testing	Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy	After the final HBOT