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Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457025
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : March 7, 2018
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bell Palsy Drug: Oral Corticosteroids Drug: Oral antivirals Device: Hyperbaric Oxygen Therapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care Therapy
Reference Therapy
Drug: Oral Corticosteroids
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg

Drug: Oral antivirals
acyclovir 400mg: one pill 4 times daily for 7 days

Experimental: Standard of Care + HOTB
Reference therapy in addition to Hyperbaric Oxygen Therapy
Drug: Oral Corticosteroids
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg

Drug: Oral antivirals
acyclovir 400mg: one pill 4 times daily for 7 days

Device: Hyperbaric Oxygen Therapy
2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis.




Primary Outcome Measures :
  1. Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group [ Time Frame: 3, 6 and 12 months ]
  2. Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care + Hyperbaric Oxygen Therapy on Bells Palsy (HBOT) Group [ Time Frame: 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Short Form 36 (SF-36) Score Standard of Care Group [ Time Frame: 3, 6 and 12 months ]
    As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health

  2. Short Form 36 (SF-36) Score Standard of Care + HBOT [ Time Frame: 3, 6 and 12 months ]
    As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health

  3. Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group [ Time Frame: 3, 6 and 12 months ]
    Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.

  4. Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT [ Time Frame: 3, 6 and 12 months ]
    Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.

  5. Facial Disability Index (FDI) Score Standard of Care Group [ Time Frame: 3, 6 and 12 months ]
    Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"

  6. Facial Disability Index (FDI) Score Standard of Care + HBOT [ Time Frame: 3, 6 and 12 months ]
    Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457025


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jeffrey Markey, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03457025    
Other Study ID Numbers: 17-01740
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Only as pertains to study results, will be shared only during publication.
Supporting Materials: Study Protocol
Time Frame: Immediately following publication. No end date.
Access Criteria: Only shared with publication.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by NYU Langone Health:
Oxygen Therapy
Bells Palsy
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Antiviral Agents
Anti-Infective Agents