Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Status: | Not yet recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2019 |
Start Date: | June 2019 |
End Date: | June 2020 |
Contact: | Judy Lee |
Email: | judy.lee@nyumc.org |
Phone: | 646 501 7906 |
This is a randomized, single blinded, non-placebo controlled that will compare one group of
Bells Palsy patients receiving the current standard of care including oral corticosteroids
and oral antivirals against an experimental group receiving the current standard of care in
addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective
analyses of facial movements as well as subjective quality of life scales.
Bells Palsy patients receiving the current standard of care including oral corticosteroids
and oral antivirals against an experimental group receiving the current standard of care in
addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective
analyses of facial movements as well as subjective quality of life scales.
Inclusion Criteria:
- 18 years or older exhibiting unilateral facial paralysis progressing to completion in
4 days or less.
Exclusion Criteria:
- No patients from vulnerable populations as listed above will be included.
- Subjects must be able to travel to NYULMC continually during the first 12 months
following enrollment.
- During the initial visit candidates must have no associated clinical signs or symptoms
consistent with other causes of facial palsy. This includes but is not limited to:
auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence
of other cranial or distal neuropathies excluding facial numbness, change in taste,
and/or hyperacusis.
- Patients with atypical presentations will be referred for cross-sectional imaging and
excluded.
- Patients with histories consistent with possible recent tick exposure, rashes,
headaches, or excessive fatigue will be serologically tested for Lyme disease and
excluded if it returns positive.
- Pneumothorax within the last two years is the only absolute medical exclusion criteria
(FF).
- Patients who are epileptics, or are claustrophobic, will be carefully counseled on the
risks of HBOT before being allowed to enroll.
- Patients with severe comorbidities will undergo evaluation by their primary care
doctor and require physician approval prior to enrollment.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Jeffrey Markey, MD
Phone: 646-501-7906
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