Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Trau... | NCT00594503

Studies
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

NCT00594503

Sponsor

Paul G. Harch, M.D.

Status

Unknown status

Last Update Posted

Apr 18, 2017Actual

Enrollment

45Estimated

Phase

Phase 1

Conditions

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

Interventions

Hyperbaric oxygen therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2017

Last Update Posted Date

Apr 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New OrleansSponsor-Investigator

Lead Sponsor

Paul G. Harch, M.D.OTHER

Collaborators

Name	Class
Harch Hyperbaric Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperbaric oxygen therapy-TBI	Experimental	Low pressure hyperbaric oxygen therapy	Drug: Hyperbaric oxygen therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric oxygen therapy	Drug	Total body exposure to increased atmospheric pressure oxygen	Hyperbaric oxygen therapy-TBI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SPECT brain imaging	Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy	After completion of HBOT

Secondary Outcomes

Measure	Description	Time Frame
Clinical history and physical exam		After completion of HBOT
Cognitive testing	Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul G Harch, M.D.	Contact	504-309-4948		paulharchmd@gmail.com

Overall Officials

Name	Affiliation	Role
Paul G Harch, M.D.	LSU School of Medicine, New Orleans	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Physicians Center	Recruiting	Marrero	Louisiana	70072	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided