Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness

NCT ID: NCT02105194

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Decompression Illness, All Phases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyperbaric oxygen therapy

Hyperbaric oxygen therapy

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type DRUG

total body exposure to greater than atmospheric pressure oxygen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperbaric oxygen therapy

total body exposure to greater than atmospheric pressure oxygen

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harch Hyperbaric Research Foundation

OTHER

Sponsor Role collaborator

Paul G. Harch, M.D.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul G. Harch, M.D.

Clinical Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul G Harch, M.D.

Role: PRINCIPAL_INVESTIGATOR

LSU School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Family Physicians Center

Marrero, Louisiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul G Harch, M.D.

Role: CONTACT

504-309-4948

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paul G Harch, M.D.

Role: primary

504-309-4948

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LSU IRB #6627

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperbaric Treatment of Traumatic Brain Injury (TBI)
NCT01847755 COMPLETED PHASE1/PHASE2
Inhaled Nitric Oxide in Brain Injury
NCT03260569 COMPLETED PHASE3