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Acute Unilateral Vestibular DeafferentiationActivationNCT04979598

Unravelling Risk Factors for Chronic Dizziness in Patients After an Acute Unilateral Vestibular Deafferentiation.

An observational study of Acute Unilateral Vestibular Deafferentiation, run by Universiteit Antwerpen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In many patients with an acute unilateral vestibular deafferentiation (uVD) syndrome symptoms are expected to resolve spontaneously because of central compensation. However, more detailed observations have revealed that 29-66 % of uVD patients develop disabling chronic dizziness lasting >1 year after the acute event. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home exercise program
How many people
103 participants
Where
1 siteBelgium
Study dates
3 Jun 2021to 1 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with an acute unilateral vestibular deafferentiation

Who may be able to join

  • Acute unilateral vestibular deafferentiation

Who cannot join

  • Central pathologies and bilateral vestibulopathies

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • University of Antwerp

    Antwerp, Antwerpen, 2610

Other trials in Belgium

About this study

Official title: Unravelling Risk Factors for Chronic Dizziness in Patients After an Acute Unilateral Vestibular Deafferentiation Syndrome.

In many patients with an acute unilateral vestibular deafferentiation (uVD) syndrome symptoms are expected to resolve spontaneously because of central compensation. However, more detailed observations have revealed that 29-66 % of uVD patients develop disabling chronic dizziness lasting >1 year after the acute event. Identifying predictors of chronic dizziness would allow patients at high risk to be targeted with personalized therapies to reduce healthcare costs. Therefore, the main objective of this study is to identify predictors of chronic dizziness after an acute uVD. Despite the consensus on the usefulness of physical therapy, incorporation of physical therapy programs in daily management of patients after acute uVD remains troublesome. Therefore, the first objective is to study the effect of the actual level of physical activity in the acute stage on long term (LT) outcome. Recent data show that LT prognosis is more linked to anxiety and somatization traits than to objective vestibular findings. Therefore, the second objective is to study the effect of activities avoidance behavior on LT outcome. As stated above it is questioned whether objective vestibular findings can predict chronicity. However recently the Perez and Rey(PR) score was developed. Therefore, the third objective is to study the effect of early central vestibular compensation as measured by the PR score on LT outcome. In patients with poor central vestibular compensation the remaining sensory cues will need to compensate for the loss of vestibular information. Patients using a visual compensation strategy can become dependent of stable visual cues. Therefore, the fourth objective is to study the effect of visual motion sensitivity on LT outcome. A 2-year prospective cohort study will be performed to study aforementioned risk factors for chronic dizziness. Up to 200 consecutive patients with an acute uVD will be included. Chronic dizziness is indicated by a score >30 on the Dizziness Handicap Inventory (primary outcome) after 6 months. Possible risk factors will be evaluated by using MOX1-activity loggers (objective 1), the Vestibular Activities Avoidance Inventory (objective 2), video Head Impulse Testing including the Perez \& Rey score (objective 3), Subjective Visual Vertical test and Rod \& Disc test (objective 4). Measurements will be taken in the acute phase and 4, 10, 26 and 52 weeks after the acute event.

Read the detailed description

In humans, acute unilateral peripheral vestibular dysfunction, whether by disease, accident, toxicity or iatrogenic, produces the unilateral vestibular deafferentiation (uVD) syndrome. In many patients, it resolves spontaneously and more or less completely because of central compensation. However, more detailed observations have revealed that 29-66% of uVD patients develop disabling chronic dizziness that lasts more than 1 year after the acute event, irrespective of the underlying etiology and regardless of the way the chronic complaints are documented: clinical bedside tests, vestibulo-ocular reflex(VOR) measurements, balance performance or perceived handicap. Although these chronic symptoms are not severe or life-threatening, they generate significant personal and social handicap in patients, leading to frequent consultations in general practice, Ear-Nose-Throat(ENT) and neurology clinics. A recent epidemiologic study revealed a prevalence of 6.5% of peripheral vestibular disorders in 70.315.919 patients in Germany thereby demonstrating its impact on society in a developed country. Identifying predictors of the "acute-to-chronic" dizziness transition would allow patients at high risk for developing chronic dizziness to be targeted with personalized therapies to reduce healthcare costs. In addition, up to 50% of patients with a chronic vestibular syndrome have a risk of developing depression or anxiety disorders. Therefore, the main objective of this study is to identify predictors of chronicity with a focus on investigating the effect of patients' tendency to avoid complaint-triggering movements and the actual level of physical activity on long-term outcomes in patients after acute uVD. Medical treatment in the acute phase is currently focused on symptomatic treatment with antivertiginous drugs (antihistamines) while motivating and helping patients to move as quickly as possible, an essential part of vestibular rehabilitation. There is moderate to strong evidence that vestibular rehabilitation is a safe, effective management for unilateral peripheral vestibular dysfunction, based on a number of high-quality randomized controlled trials. Furthermore, there is moderate evidence that vestibular rehabilitation resolves symptoms and improves functioning in the intermediate term but there is insufficient evidence to discriminate between different forms of vestibular rehabilitation. Based on a clinical practice guideline from the American Physical Therapy Association (Neurology Section),clinicians may offer specific exercise techniques to target identified impairments or functional limitations and may provide supervised vestibular rehabilitation. Despite the consensus on the usefulness of physical therapy, incorporation of physical therapy programs in daily management of patients after acute uVD remains troublesome. Research into health care utilization in patients with dizziness revealed a low number of visits for vestibular disorders were referred to physical therapy in ambulatory care. Moreover, the confrontation with current practice and the review of research protocols that study long-term outcome after an acute uVD show that the approach usually consists of encouraging patients to move a round as much as possible without the supervision of the physical therapist. Early and active vestibular rehabilitation is crucial. However, there are no known studies that investigate the actual physical activity level and/or exercise adherence in home exercise programs in patients with acute uVD. Therefore, our first objective is to study the effect of physical activity/movement volume in the acute stage on long term outcome after an acute uVD. Furthermore, psychological factors such as anxiety, depression and fear of falling have a negative effect on the outcome of vestibular rehabilitation. Indeed, recent data show that long-term prognosis in vestibular neuritis patients is more linked to anxiety and somatization traits than to objective vestibular findings. Pathophysiologic processes seem to include precipitating events that trigger anxiety-related changes in postural strategies with an increased attention to head and body motion and a cocontraction of leg muscles. Fear of movement in response to injury is a concept first introduced in the field of chronic low back pain, where it was shown that fear of inducing or increasing pain could lead to a maladaptive response of restricting movements and activities. In contrast, the confrontation response leads to increased movement and return to activities. This model can be translated to vestibular disorders as avoiding complaint-inducing movements is a known compensation strategy used by patients with an acute uVD. These physical activities are very important to promote compensation and avoiding them can therefore contribute to greater disability. Therefore, the second objective is to study the effect of activities avoidance behavior on long term outcome after an acute uVD. Acute uVD is defined by the patient history, the clinical examination and often characterized by measurable vestibular parameters using three-dimensional video head impulse testing (vHIT), caloric irrigation, sinusoidal harmonious acceleration testing (SHA) and cervical/ocular vestibular-evoked myogenic potentials (c/o VEMP). However, whether these VOR function measurements can predict chronicity is questioned. Recently a new tool (i.e. the Perez and Rey (PR) score) was developed to characterize the state of vestibular compensation of subjects diagnosed with acute uVD of peripheral origin. The PR score is a measure of temporal organization of the refixation saccades that enables to distinguish clearly and objectively between subjects that are in a compensated or uncompensated vestibular situation. However the PR score has never been studied as a prognostic factor of progression to chronicity. Therefore, the third objective is to study the effect of early central vestibular compensation as measured by the PR score on long term outcome after an acute uVD. Accurate perception of gravity is important for spatial orientation, postural balance, and the regulation of gait. Multiple sensory signals contribute to the central processing of this percept, including signals from visual, vestibular and somatosensory systems. Patients after an acute uVD suffer from a deteriorated sense of spatial orientation, leading to balance problems. In uncompensated vestibular patients the remaining sensory cues will need to compensate for the loss of vestibular information. Recently a reweighting of sensory signals with an increase in visual weight of 20-40% was suggested in patients with a bilateral vestibular function loss. This visual compensation strategy can make some patients dependent of stable visual cues which might lead to visual motion sensitivity. Evidence is mounting that visual field dependency is also a factor contributing to visual vertigo in patients with vestibular disorders. Visually induced dizziness or visual vertigo is a specific form of persistent perceptual postural dizziness which is classified as a chronic functional vestibular disorder. Therefore, the fourth objective is to study the effect of visual motion sensitivity on long term outcome after an acute uVD.

Being tested
Home exercise program
Keywords
Vestibular Neuritis, Labyrinthitis, Vestibular Neurectomy, Resection Vestibular Schwannoma, Gentamicin Injection
Medical subject headings
Vestibular Neuronitis, Labyrinthitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home exercise programOther

    A home exercise program is provided but this is an observational study. The effect of the exercise program is not under investigation.

Study groups in NCT04979598
Study groupRoleWhat they receive
Acute unilateral vestibular deafferentiationPatients suffering from acute dizziness due to a unilateral vestibular deafferentiation.
Receives: Other: Home exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dizziness Handicap Inventory

    Questionnaire concerning impairments due to dizziness: the higher the score, the bigger the perceived handicap due to dizziness.

    Measured: 6 months

Secondary outcomes (5)
  1. Perez-and Rey score

    Temporal organisation of corrective saccades

    Measured: Week 1, 4, 10, 26 & 52

  2. Mox1loggers

    Level of physical activity

    Measured: Week 1 & 10

  3. Rod&Disc test

    Visual dependency

    Measured: Week 10 & 26

  4. Anxiety

    Hospital Anxiety and Depression Scale: two subscales (anxiety and depression). A lower score means less chance on an anxiety or depression disorder.

    Measured: Week 1, 4, 10, 26 & 52

  5. Avoidance behavior

    Vestibular Activities Avoidance Inventory: the higher the score, the bigger the chance that avoidance behavior is present.

    Measured: Week 1, 4, 10, 26 & 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start3 Jun 2021
  3. Primary completion30 Oct 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979598
Sponsor's protocol ID
42186
Acronym
Activation
Status last verified
Dec 2024
First submitted
6 Jul 2021
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: A registration at the Research Database Antigoon was submitted and approved. In this way a Data Protection Impact Assessment (DPIA) is performed. A Data Management was published on "dmponline.be".

Publications

  • Alberts BBGT, Selen LPJ, Verhagen WIM, Pennings RJE, Medendorp WP. Bayesian quantification of sensory reweighting in a familial bilateral vestibular disorder (DFNA9). J Neurophysiol. 2018 Mar 1;119(3):1209-1221. doi: 10.1152/jn.00082.2017. Epub 2017 Dec 13.

    PubMed 29357473
  • Batuecas-Caletrio A, Rey-Martinez J, Trinidad-Ruiz G, Matino-Soler E, Cruz-Ruiz SS, Munoz-Herrera A, Perez-Fernandez N. Vestibulo-Ocular Reflex Stabilization after Vestibular Schwannoma Surgery: A Story Told by Saccades. Front Neurol. 2017 Jan 25;8:15. doi: 10.3389/fneur.2017.00015. eCollection 2017.

    PubMed 28179894
  • Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. doi: 10.1080/00016489950180243.

    PubMed 10728930
  • Bronstein AM, Dieterich M. Long-term clinical outcome in vestibular neuritis. Curr Opin Neurol. 2019 Feb;32(1):174-180. doi: 10.1097/WCO.0000000000000652.

    PubMed 30566414
  • Cousins S, Cutfield NJ, Kaski D, Palla A, Seemungal BM, Golding JF, Staab JP, Bronstein AM. Visual dependency and dizziness after vestibular neuritis. PLoS One. 2014 Sep 18;9(9):e105426. doi: 10.1371/journal.pone.0105426. eCollection 2014.

    PubMed 25233234
  • Cousins S, Kaski D, Cutfield N, Arshad Q, Ahmad H, Gresty MA, Seemungal BM, Golding J, Bronstein AM. Predictors of clinical recovery from vestibular neuritis: a prospective study. Ann Clin Transl Neurol. 2017 Mar 22;4(5):340-346. doi: 10.1002/acn3.386. eCollection 2017 May.

    PubMed 28491901
  • Dieterich M, Staab JP. Functional dizziness: from phobic postural vertigo and chronic subjective dizziness to persistent postural-perceptual dizziness. Curr Opin Neurol. 2017 Feb;30(1):107-113. doi: 10.1097/WCO.0000000000000417.

    PubMed 28002123
  • Eckhardt-Henn A, Breuer P, Thomalske C, Hoffmann SO, Hopf HC. Anxiety disorders and other psychiatric subgroups in patients complaining of dizziness. J Anxiety Disord. 2003;17(4):369-88. doi: 10.1016/s0887-6185(02)00226-8.

    PubMed 12826087
  • Godemann F, Siefert K, Hantschke-Bruggemann M, Neu P, Seidl R, Strohle A. What accounts for vertigo one year after neuritis vestibularis - anxiety or a dysfunctional vestibular organ? J Psychiatr Res. 2005 Sep;39(5):529-34. doi: 10.1016/j.jpsychires.2004.12.006. Epub 2005 Mar 4.

    PubMed 15992562
  • Goto F, Sugaya N, Arai M, Masuda K. Psychiatric disorders in patients with intractable dizziness in the department of otolaryngology. Acta Otolaryngol. 2018 Jul;138(7):646-647. doi: 10.1080/00016489.2018.1429652. Epub 2018 Jan 31.

    PubMed 29385877
  • Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.

    PubMed 24604142
  • Guajardo-Vergara C, Perez-Fernandez N. A New and Faster Method to Assess Vestibular Compensation: A Cross-Sectional Study. Laryngoscope. 2020 Dec;130(12):E911-E917. doi: 10.1002/lary.28505. Epub 2020 Feb 7.

    PubMed 32031691
  • Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Treatment for Vestibular Disorders: How Does Your Physical Therapist Treat Dizziness Related to Vestibular Problems? J Neurol Phys Ther. 2016 Apr;40(2):156. doi: 10.1097/01.NPT.0000481898.55592.6e. No abstract available.

    PubMed 26934418
  • Halmagyi GM, Weber KP, Curthoys IS. Vestibular function after acute vestibular neuritis. Restor Neurol Neurosci. 2010;28(1):37-46. doi: 10.3233/RNN-2010-0533.

    PubMed 20086281
  • Hulse R, Biesdorf A, Hormann K, Stuck B, Erhart M, Hulse M, Wenzel A. Peripheral Vestibular Disorders: An Epidemiologic Survey in 70 Million Individuals. Otol Neurotol. 2019 Jan;40(1):88-95. doi: 10.1097/MAO.0000000000002013.

    PubMed 30289843

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Unilateral Vestibular Deafferentiation, run by Universiteit Antwerpen at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dizziness Handicap Inventory (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04979598, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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