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Oxygen Toxicity of HBOT in Chronic Brain Injury

Primary Purpose

Adult and Pediatric Chronic Cerebral Disorders

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric oxygen therapy

About this trial

This is an interventional treatment trial for Adult and Pediatric Chronic Cerebral Disorders focused on measuring brain injury, brain disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cerebral disorder of greater than one year's duration

Exclusion Criteria:

None

Sites / Locations

Family Physicians CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric oxygen therapy

Arm Description

Patients undergoing low pressure HBOT for chronic brain injury

Outcomes

Primary Outcome Measures

Oxygen toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00592891

First Posted

January 2, 2008

Last Updated

January 1, 2015

Sponsor

Paul G. Harch, M.D.

Collaborators

Harch Hyperbaric Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00592891

Brief Title

Oxygen Toxicity of HBOT in Chronic Brain Injury

Official Title

Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2002 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul G. Harch, M.D.

Collaborators

Harch Hyperbaric Research Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult and Pediatric Chronic Cerebral Disorders

Keywords

brain injury, brain disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperbaric oxygen therapy

Arm Type

Experimental

Arm Description

Patients undergoing low pressure HBOT for chronic brain injury

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen therapy

Intervention Description

Total body pressurized oxygen

Primary Outcome Measure Information:

Title

Oxygen toxicity

Time Frame

After completion of hyperbaric oxygen therapy

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cerebral disorder of greater than one year's duration Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul G Harch, M.D.

Phone

504-309-4948

paulharchmd@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul G Harch, M.D.

Organizational Affiliation

LSU School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Family Physicians Center

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul G Harch, M.D.

Phone

504-309-4948

paulharchmd@gmail.com

First Name & Middle Initial & Last Name & Degree

Paul G Harch, M.D.

12. IPD Sharing Statement

Learn more about this trial

Oxygen Toxicity of HBOT in Chronic Brain Injury

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