Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies
1 other identifier
interventional
74
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 26, 2011
December 1, 2011
2.2 years
July 14, 2008
December 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurologic evaluation
2 and 4 months
Study Arms (2)
Treatment- HBOT
EXPERIMENTALHBOT treatment: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
control-HBOT
NO INTERVENTIONCross 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
Interventions
8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Eligibility Criteria
You may not qualify if:
- Dynamic neurologic improvement or worsening during the last 4 weeks.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Asaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
Research & Development unit, Asaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (1)
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.
PMID: 23335971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical center
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 15, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2010
Study Completion
November 1, 2011
Last Updated
December 26, 2011
Record last verified: 2011-12