Recruiting
Phase 1

Hyperbaric Oxygen Therapy

Sponsor:

Paul G. Harch, M.D.

Code:

NCT00594503

Conditions

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

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric oxygen therapy

Study Details

Brief 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.

Conditions

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

Study ID

NCT00594503

Start date

Jan, 2007

Status verified date

Apr, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyperbaric oxygen therapy-TBI

Low pressure hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy

Total body exposure to increased atmospheric pressure oxygen

Primary outcome measure

  • SPECT brain imaging [ Time Frame: After completion of HBOT ]

Central Contacts and Locations

Central contacts

Locations

Family Physicians Center

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Principal Investigator:

Paul G Harch, M.D.

More Information

Sponsor

Paul G. Harch, M.D.

Last update posted

Apr 18, 2017

Last verified

Apr, 2017

Keywords

  • traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Paul G. Harch, M.D. on 2017-04-18.