Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

NCT ID: NCT03457025

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-06-30

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.

Conditions

Bell Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care Therapy

Reference Therapy

Group Type: ACTIVE_COMPARATOR

Oral Corticosteroids

Intervention Type: DRUG

Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg

Oral antivirals

Intervention Type: DRUG

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

Standard of Care + HOTB

Reference therapy in addition to Hyperbaric Oxygen Therapy

Group Type: EXPERIMENTAL

Oral Corticosteroids

Intervention Type: DRUG

Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg

Oral antivirals

Intervention Type: DRUG

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

Hyperbaric Oxygen Therapy

Intervention Type: DEVICE

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.

Interventions

Oral Corticosteroids

Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg

Intervention Type: DRUG

Oral antivirals

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Markey, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01740

Identifier Type: -

Identifier Source: org_study_id