NCT06213415

Brief Summary

intratympanic steroid injection bell's palsy

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2024Nov 2026

First Submitted

Initial submission to the registry

November 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

November 28, 2023

Last Update Submit

January 9, 2024

Conditions

Bell Palsy

Outcome Measures

Primary Outcomes (1)

  • Success or failure of procedure to treat Bell's palsy

    Degree of regaining function to facial nerve Unit of measurement : nerve conduction study Measurement tool :endoscopic injection by ear microscope

    6 months

Study Arms (2)

Oral steroids

ACTIVE COMPARATOR

Oral steroids only

Drug: Corticosteroid

Oral steroids plus intratympanic injections

ACTIVE COMPARATOR

Oral steroids plus intratympanic injections

Drug: Corticosteroid

Interventions

CorticosteroidDRUG

Oral steroids plus intratympanic injection

Oral steroidsOral steroids plus intratympanic injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mean Aged 18 years or more.
  • Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
  • Moderate to severe facial palsy \[House-Brackmann grade IV or greater\]

You may not qualify if:

  • Another cause of facial nerve paralysis that is not idiopathic.
  • Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
  • Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Agostini F, Mangone M, Santilli V, Paoloni M, Bernetti A, Saggini R, Paolucci T. Idiopathic facial palsy: umbrella review of systematic reviews and meta-analyses. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4):1245-1255. doi: 10.23812/20-339-A.

    PMID: 32935528BACKGROUND

  • Chang CWD, McCoul ED, Briggs SE, Guardiani EA, Durand ML, Hadlock TA, Hillel AT, Kattar N, Openshaw PJM, Osazuwa-Peters N, Poetker DM, Shin JJ, Chandrasekhar SS, Bradford CR, Brenner MJ. Corticosteroid Use in Otolaryngology: Current Considerations During the COVID-19 Era. Otolaryngol Head Neck Surg. 2022 Nov;167(5):803-820. doi: 10.1177/01945998211064275. Epub 2021 Dec 7.

    PMID: 34874793BACKGROUND

  • Hernandez-Trejo AF, Cuellar-Calderon KP, Trevino-Gonzalez JL, Yamamoto-Ramos M, Campos-Coy MA, Quiroga-Garza A, Guzman-Avilan K, Elizondo-Riojas G, Elizondo-Omana RE, Guzman-Lopez S. Prevalence of facial canal dehiscence and other bone defects by computed tomography. Eur Arch Otorhinolaryngol. 2020 Oct;277(10):2681-2686. doi: 10.1007/s00405-020-06013-8. Epub 2020 May 7.

    PMID: 32383094BACKGROUND

  • Inagaki A, Minakata T, Katsumi S, Murakami S. Concurrent Treatment With Intratympanic Dexamethasone for Moderate-Severe Through Severe Bell's Palsy. Otol Neurotol. 2019 Dec;40(10):e1018-e1023. doi: 10.1097/MAO.0000000000002377.

    PMID: 31469789BACKGROUND

  • Volk GF, Schaede RA, Thielker J, Modersohn L, Mothes O, Nduka CC, Barth JM, Denzler J, Guntinas-Lichius O. Reliability of grading of facial palsy using a video tutorial with synchronous video recording. Laryngoscope. 2019 Oct;129(10):2274-2279. doi: 10.1002/lary.27739. Epub 2018 Dec 20.

    PMID: 30570149BACKGROUND

  • Walker NR, Mistry RK, Mazzoni T. Facial Nerve Palsy. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549815/

    PMID: 31747222BACKGROUND

MeSH Terms

Conditions

Bell Palsy

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ahmed Ragab sayed

    Board membership

    STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Alaa

CONTACT

01007575074Drahmedm.alaaa@gmail.com

Hussein Farid mostafa wishahi

CONTACT

01001775898hussien.weshahi@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

November 28, 2023

First Posted

January 19, 2024

Study Start

February 1, 2024

Primary Completion

April 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

January 19, 2024

Record last verified: 2024-01