Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

Bell Palsy Clinical Trial

Official title:

Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03457025
• Other study ID #: 17-01740
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: August 2019
• Est. completion date: June 2020

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Paralysis

Intervention

Drug:
• Oral Corticosteroids
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Short Form 36 (SF-36) Score Standard of Care Group	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, 6 and 12 months
Secondary	Short Form 36 (SF-36) Score Standard of Care + HBOT	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, 6 and 12 months
Secondary	Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group	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.	3, 6 and 12 months
Secondary	Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT	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.	3, 6 and 12 months
Secondary	Facial Disability Index (FDI) Score Standard of Care Group	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"	3, 6 and 12 months
Secondary	Facial Disability Index (FDI) Score Standard of Care + HBOT	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"	3, 6 and 12 months