Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
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Purpose
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 | Intervention |
|---|---|
|
Chronic Neurological Deficiency Stroke |
Procedure: Hyperbaric Oxygen Therapy (HBOT) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
- Neurologic evaluation [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | August 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided by Assaf-Harofeh Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fany Tusia, medical center, Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00715897 History of Changes |
| Other Study ID Numbers: | HBOcva1 |
| Study First Received: | July 14, 2008 |
| Last Updated: | December 23, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Assaf-Harofeh Medical Center:
|
chronic neurological deficient due to stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013