Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

NCT ID: NCT00594503

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy-TBI

Low pressure hyperbaric oxygen therapy

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type DRUG

Total body exposure to increased atmospheric pressure oxygen

Interventions

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Hyperbaric oxygen therapy

Total body exposure to increased atmospheric pressure oxygen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harch Hyperbaric Research Foundation

OTHER

Sponsor Role collaborator

Paul G. Harch, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Paul G. Harch, M.D.

Clinical Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul G Harch, M.D.

Role: PRINCIPAL_INVESTIGATOR

LSU School of Medicine, New Orleans

Locations

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Family Physicians Center

Marrero, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul G Harch, M.D.

Role: CONTACT

504-309-4948

Facility Contacts

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Paul G Harch, M.D.

Role: primary

504-309-4948

Other Identifiers

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LSU IRB #6625

Identifier Type: -

Identifier Source: org_study_id

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