Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

NCT03821155 | Completed

• 1 other identifier: 2018-166
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

Conditions

Vestibular Neuritis

Keywords

Vestibular Neuritis; SHIMP (suppressing head impulse paradigm); SVV (subjective visual vertical); Vestibular rehabilitation; Prednisolone; v-HIT (video head impulse test); Vestibular Neuronitis

Outcome Measures

Primary Outcomes (4)

• Suppressing head impulse paradigm (SHIMP)

  SHIMP equipment will objectively quantify change of vestibular function.

  6 month

• Subjective visual vertical (SVV)

  SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function

  6 month

• Video head impulse test (v-HIT)

  v-HIT equipment will objectively quantify change of vestibular function.

  6 month

• Dizziness handicap inventory (DHI) questionnaire

  Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

  6 month

Study Arms (2)

Neuritis vestibularis (group 1)

ACTIVE COMPARATOR

Corticosteroid ("prednisolone")

Drug: Corticosteroid

Neuritis vestibularis (group 2)

EXPERIMENTAL

Corticosteroid ("prednisolone") + vestibular rehabilitation

Other: Vestibular rehabilitation; Drug: Corticosteroid

Interventions

Vestibular rehabilitation OTHER

Specialized physical therapy aimed at restoring balance

Neuritis vestibularis (group 2)

Corticosteroid DRUG

Prednisolone

Neuritis vestibularis (group 1); Neuritis vestibularis (group 2)

Eligibility Criteria

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

You may qualify if:

• Age above 18 years of age
• Medical history compatible with vestibular neuritis
• Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

You may not qualify if:

• Former medical history with vestibular dysfunction
• Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
• Onset of symptoms 14 days before recruitment to the study
• Focal neurological symptoms/signs
• Contraindication to prednisolone treatment
• Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Vestibular Neuronitis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dan D Hougaard, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Martin H Wolder, MS

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: Patients randomized to two different treatments: 1. corticosteroid treatment ("prednisolone") 2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)