NCT00594503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

10.9 years

First QC Date

January 3, 2008

Last Update Submit

April 16, 2017

Conditions

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

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • SPECT brain imaging

    Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy

    After completion of HBOT

Secondary Outcomes (2)

  • Clinical history and physical exam

    After completion of HBOT

  • Cognitive testing

    After the final HBOT

Study Arms (1)

Hyperbaric oxygen therapy-TBI

EXPERIMENTAL

Low pressure hyperbaric oxygen therapy

Drug: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyDRUG

Total body exposure to increased atmospheric pressure oxygen

Hyperbaric oxygen therapy-TBI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Physicians Center

Marrero, Louisiana, 70072, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Paul G Harch, M.D.

    LSU School of Medicine, New Orleans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul G Harch, M.D.

CONTACT

504-309-4948paulharchmd@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor of Medicine

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)