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

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

Tracking Information

• First Submitted Date: July 14, 2008
• First Posted Date: July 15, 2008
• Last Update Posted Date: December 26, 2011
• Study Start Date: August 2008
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 14, 2008): Neurologic evaluation [ Time Frame: 2 and 4 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
• Official Title: Not Provided
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Neurological Deficiency
• Stroke

Intervention

Procedure: Hyperbaric Oxygen Therapy (HBOT)

8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.

Study Arms

• Experimental: Treatment- HBOT
  HBOT treatment: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
  Intervention: Procedure: Hyperbaric Oxygen Therapy (HBOT)
• 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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 23, 2011): 74
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00715897
• Other Study ID Numbers: HBOcva1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fany Tusia, Assaf-Harofeh Medical Center
• Original Responsible Party: Shai Efrati, Assaf-Harofeh Medical Center
• Current Study Sponsor: Assaf-Harofeh Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assaf-Harofeh Medical Center
• Verification Date: December 2011