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Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies

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ClinicalTrials.gov Identifier: NCT00715897
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : December 26, 2011
Sponsor:
Information provided by (Responsible Party):
Fany Tusia, Assaf-Harofeh Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Neurological Deficiency Stroke Procedure: Hyperbaric Oxygen Therapy (HBOT) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment- HBOT
HBOT treatment: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
 Procedure: Hyperbaric Oxygen Therapy (HBOT)
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
No Intervention: control-HBOT
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


Outcome Measures
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Primary Outcome Measures :
  1. Neurologic evaluation [ Time Frame: 2 and 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715897


Locations
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Israel
Asaf-Harofeh Medical Center
Zerifin, Israel, 70300
Research & Development unit, Asaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fany Tusia, medical center, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00715897    
Other Study ID Numbers: HBOcva1
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: December 26, 2011
Last Verified: December 2011
Keywords provided by Fany Tusia, Assaf-Harofeh Medical Center:
chronic neurological deficient due to stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases