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NCT Number: NCT00715897

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asaf-Harofeh Medical Center, Ẕerifin, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric Oxygen Therapy (HBOT)

Procedure

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

Primary outcomes

  1. Neurologic evaluation

    Time frame: 2 and 4 months

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 15, 2008
Registry last updated
Dec 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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