NCT00592891

Brief Summary

Hypothesis: That HBOT can be toxic in the low-pressure range.

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 Apr 2002

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

April 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

14.7 years

First QC Date

January 2, 2008

Last Update Submit

January 1, 2015

Conditions

Adult and Pediatric Chronic Cerebral Disorders

Keywords

brain injurybrain disorders

Outcome Measures

Primary Outcomes (1)

  • Oxygen toxicity

    After completion of hyperbaric oxygen therapy

Study Arms (1)

Hyperbaric oxygen therapy

EXPERIMENTAL

Patients undergoing low pressure HBOT for chronic brain injury

Drug: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyDRUG

Total body pressurized oxygen

Hyperbaric oxygen therapy

Eligibility Criteria

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

You may qualify if:

  • Cerebral disorder of greater than one year's duration

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 InjuriesBrain Diseases

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Central 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

    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 2, 2008

First Posted

January 14, 2008

Study Start

April 1, 2002

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2015

Record last verified: 2015-01

Locations

US(1)