Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

Early Phase 1

Withdrawn

• Conditions: Bell Palsy
• Interventions: Drug: Oral Corticosteroids; Drug: Oral antivirals; Device: Hyperbaric Oxygen Therapy

• Registration Number: NCT03457025
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Study Start: 2019-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + HOTB	Oral antivirals	Reference therapy in addition to Hyperbaric Oxygen Therapy
Standard of Care Therapy	Oral antivirals	Reference Therapy
Standard of Care Therapy	Oral Corticosteroids	Reference Therapy
Standard of Care + HOTB	Oral Corticosteroids	Reference therapy in addition to Hyperbaric Oxygen Therapy
Standard of Care + HOTB	Hyperbaric Oxygen Therapy	Reference therapy in addition to Hyperbaric Oxygen Therapy

Primary Outcome Measures

Name	Time	Method
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group	3, 6 and 12 months
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	3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Short Form 36 (SF-36) Score Standard of Care Group	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
Facial Disability Index (FDI) Score Standard of Care + HBOT	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"
Short Form 36 (SF-36) Score Standard of Care + HBOT	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
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group	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.
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT	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.
Facial Disability Index (FDI) Score Standard of Care Group	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"

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States