Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

NCT03457025 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 17-01740
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Oxygen Therapy; Bells Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Short Form 36 (SF-36) Score Standard of Care Group

  3, 6 and 12 months

• Short Form 36 (SF-36) Score Standard of Care + HBOT

  3, 6 and 12 months

• Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group

  3, 6 and 12 months

• Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT

  3, 6 and 12 months

• Facial Disability Index (FDI) Score Standard of Care Group

  3, 6 and 12 months

Study Arms (2)

Standard of Care Therapy

ACTIVE COMPARATOR

Reference Therapy

Drug: Oral Corticosteroids; Drug: Oral antivirals

Standard of Care + HOTB

EXPERIMENTAL

Reference therapy in addition to Hyperbaric Oxygen Therapy

Drug: Oral Corticosteroids; Drug: Oral antivirals; Device: Hyperbaric Oxygen Therapy

Interventions

Oral Corticosteroids DRUG

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

Standard of Care + HOTB; Standard of Care Therapy

Oral antivirals DRUG

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

Standard of Care + HOTB; Standard of Care Therapy

Hyperbaric Oxygen Therapy 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.

Standard of Care + HOTB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Bell Palsy

Interventions

Adrenal Cortex Hormones; Antiviral Agents; Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Jeffrey Markey, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: March 7, 2018
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Only shared with publication.

Locations

US (1)