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Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Primary Purpose

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

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 Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury focused on measuring traumatic brain injury

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

None

Sites / Locations

Family Physicians CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric oxygen therapy-TBI

Arm Description

Low pressure hyperbaric oxygen therapy

Outcomes

Primary Outcome Measures

SPECT brain imaging

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

Secondary Outcome Measures

Clinical history and physical exam

Cognitive testing

Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy

Full Information

NCT ID

NCT00594503

First Posted

January 3, 2008

Last Updated

April 16, 2017

Sponsor

Paul G. Harch, M.D.

Collaborators

Harch Hyperbaric Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00594503

Brief Title

Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Official Title

Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (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 SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

Detailed 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.

6. Conditions and Keywords

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

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

Keywords

traumatic brain injury

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-TBI

Arm Type

Experimental

Arm Description

Low pressure hyperbaric oxygen therapy

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen therapy

Intervention Description

Total body exposure to increased atmospheric pressure oxygen

Primary Outcome Measure Information:

Title

SPECT brain imaging

Description

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

Time Frame

After completion of HBOT

Secondary Outcome Measure Information:

Title

Clinical history and physical exam

Time Frame

After completion of HBOT

Title

Cognitive testing

Description

Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy

Time Frame

After the final HBOT

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults or children with traumatic brain injury at least one year old 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, New Orleans

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

Plan to Share IPD

Learn more about this trial

Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

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