NCT02452619

Brief Summary

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment. The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

April 15, 2015

Last Update Submit

October 23, 2016

Conditions

Keywords

Hyperbaric oxygen therapybrain traumacognitive impairment

Outcome Measures

Primary Outcomes (2)

  • Perfusion MRI changes

    Before and after treatment. Treatment is approximately 3 months.

  • Microstructure changes (DTI)

    Before and after treatment. Treatment is approximately 3 months.

Study Arms (1)

Brain trauma

Patients with chronic brain injury that have been treated with Hyperbaric oxygen therapy and underwent MRI imaging and cognitive tests before and after the treatment

Other: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy

Brain trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective analysis of patients suffering from chronic neuro-cognitive damage treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel from September 2013 . Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). Treatment was approved by the institutional review board of the hospital.

You may qualify if:

  • Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).

You may not qualify if:

  • did no complete treatment or did not complete examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assaf-Harofeh Medical Center

Ẕerifin, Israel, 70300, Israel

Location

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Cognitive DysfunctionBrain Injuries, Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sigal Tal

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 22, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations