Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
Primary Purpose
Chronic Neurological Deficiency, Stroke
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy (HBOT)
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Neurological Deficiency focused on measuring chronic neurological deficient due to stroke
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older, who had ischemic stroke and 60 patients who had hemorrhagic stroke 6-18 months prior to their inclusion in the study.
Exclusion Criteria:
- Dynamic neurologic improvement or worsening during the last 4 weeks.
- Had been treated with HBO for any other reason prior to their inclusion.
- Have any other indication for HBOT
- Chest pathology incompatible with pressure changes
- Inner ear disease
- Patients suffering from claustrophobia.
- Inability to give written informed consent.
Sites / Locations
- Asaf-Harofeh Medical Center
- Research & Development unit, Asaf-Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment- HBOT
control-HBOT
Arm Description
HBOT treatment: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Cross group: Patients in the cross group were evaluated three times-baseline, after 2 months control period of no treatment and after a consequent 2 month of HBOT
Outcomes
Primary Outcome Measures
Neurologic evaluation
Secondary Outcome Measures
Full Information
NCT ID
NCT00715897
First Posted
July 14, 2008
Last Updated
December 23, 2011
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00715897
Brief Title
Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
5. Study Description
Brief Summary
The aim of the current work was to evaluate, for the first time in a prospective randomized study, the effect of HBOT on patients with chronic neurological deficiency due to stroke.
Detailed Description
Objective: Evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficiency due to stroke.
Methods: A prospective, randomized, control-crossed over trial including patients who had stroke 6-36 months prior to their inclusion. All patients had at least one motor dysfunction. After their inclusion patients were randomized to treated or cross group. The neurologic functions were evaluated by NIHSS, ADL, life quality and brain SPECT. Patients in the treated group were evaluated twice-at baseline and after HBOT. Patients in the cross group were evaluated three times-baseline, after 2 months control period of no treatment and after a consequent 2 month of HBOT. The following HBOT protocol was practice: 40 daily sessions, 90 minutes each, 100% oxygen at 2ATA, 5 days/week,.
Results: The study included 74 patients (8 were excluded). During the control period, in the cross group, NIHSS and the ADL had not changed, while in the treated group both significantly improved. After the cross-over, when the cross group received HBOT, NIHSS and ADL had significantly improved. Same trend of changes were in life quality. The SPECT correlated with the clinical improvement. The improvements were mostly in territories where there was a noticeable discrepancy between the CT and SPECT.
Interpretation: In this study, for the first time, it was demonstrated that HBOT can induce neuroplasticity in patients with chronic neurologic deficiencies due to stroke. The beneficial effect of the HBOT is mostly in territories where there is a brain SPECT/CT mismatch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neurological Deficiency, Stroke
Keywords
chronic neurological deficient due to stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment- HBOT
Arm Type
Experimental
Arm Description
HBOT treatment: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Arm Title
control-HBOT
Arm Type
No Intervention
Arm Description
Cross group: Patients in the cross group were evaluated three times-baseline, after 2 months control period of no treatment and after a consequent 2 month of HBOT
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy (HBOT)
Intervention Description
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Primary Outcome Measure Information:
Title
Neurologic evaluation
Time Frame
2 and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older, who had ischemic stroke and 60 patients who had hemorrhagic stroke 6-18 months prior to their inclusion in the study.
Exclusion Criteria:
Dynamic neurologic improvement or worsening during the last 4 weeks.
Had been treated with HBO for any other reason prior to their inclusion.
Have any other indication for HBOT
Chest pathology incompatible with pressure changes
Inner ear disease
Patients suffering from claustrophobia.
Inability to give written informed consent.
Facility Information:
Facility Name
Asaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Research & Development unit, Asaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
23335971
Citation
Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
Results Reference
derived
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Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
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