Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Overview

Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days). Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2021

Detailed Description

Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects. Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing. Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days). Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months. Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.

Interventions

  • Drug: Betamethasone
    • Betamethasone intravenous
  • Drug: Placebo
    • Placebo intravenous NaCl intravenous administration Placebo tablets
  • Drug: Prednisolone
    • Oral tablets

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
  • Active Comparator: Short treatment
    • Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
  • Active Comparator: Standard treatment
    • Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg

Clinical Trial Outcome Measures

Primary Measures

  • Caloric function
    • Time Frame: after 3 months
    • Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
  • Caloric function
    • Time Frame: 1 year
    • Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function

Secondary Measures

  • vHIT
    • Time Frame: 2-5 days after debut
    • measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological
  • Subjective visual vertical/horizontal
    • Time Frame: 2-5 days after debut,
    • Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
  • Covert saccades
    • Time Frame: 2-5 days after debut,
    • Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
  • Vertigo Diary
    • Time Frame: Daily from debut and until no subjective vertigo is experienced, longest 4 weeks
    • Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo
  • Sleep Diary
    • Time Frame: Daily from debut and 14 days onwards (2 days after last treatment)
    • Patients often experience troubled sleep when treated with corticosteroids. How much has not been assessed. The patients will assess their sleep the previous night according to a Liknert scale (1=good nights sleep, 10=hardly slept at all)
  • HADS-enquiry
    • Time Frame: 3 and 12 months after debut
    • Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness
  • VSS-enquiry
    • Time Frame: 3 and 12 months after debut
    • Vertigo sympton score, To assess vertigo symptoms
  • DHI-enquiry
    • Time Frame: 3 and 12 months after debut
    • Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life
  • VHQ-enquiry
    • Time Frame: 3 and 12 months after debut
    • Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life
  • Stress hormones
    • Time Frame: At debut and 1 year
    • Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut
  • Saliva-Cortisol
    • Time Frame: At debut and up to 1 week
    • Daily measurement of saliva cortisol as measurement of stress
  • Adverse Events
    • Time Frame: From debut to 1 year after
    • Analysis of adverse events to treatment as well as functional outcome
  • Hospital stay
    • Time Frame: From debut up to 10 days
    • Duration of hospital stay
  • vHIT
    • Time Frame: 1 year
    • measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological
  • Subjective visual vertical/horizontal
    • Time Frame: 1 month
    • Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
  • Subjective visual vertical/horizontal
    • Time Frame: 3 months
    • Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
  • Subjective visual vertical/horizontal
    • Time Frame: 1 year
    • Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
  • Covert saccades
    • Time Frame: 3 months
    • Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
  • Covert saccades
    • Time Frame: 1 year
    • Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
  • Sick-leave
    • Time Frame: debut up to 1 year
    • Time needed for sick-leave
  • Daily living
    • Time Frame: debut up to 1 year
    • Time until daily activities are as prior to th disease

Participating in This Clinical Trial

Inclusion Criteria

  • definite unilateral vestibulopathy – no pathological HINTS (examination criteria in acute vestibular syndrome) – capable of making their own decisions Exclusion Criteria:

  • tinnitus or hearing loss with same debut as vertigo – history of bleeding peptic ulcer – glaucoma – pregnancy or non-acceptance to use anticonception measures during 13 days after debut – high blood pressure >180 systolic, 105, diastolic – ketoacidosis with a Base Excess >=2 – psychic disorder (not including mild depression) – serious infection (neutropenia, tuberculosis) – chronic otitis – history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lund University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fredrik Tjernström, MD, PhD, Principal Investigator, Lund University
  • Overall Contact(s)
    • Fredrik Tjernström, MD, PhD, +46 46 175849, Fredrik.Tjernstrom@med.lu.se

References

Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;(5):CD008607. doi: 10.1002/14651858.CD008607.pub2. Review.

Citations Reporting on Results

Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61.

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