Vestibular NeuronitisNCT00411216
Recovery of Visual Acuity in People With Vestibular Deficits
A study testing gaze stabilization exercises in people with Vestibular Neuronitis and Vestibular Neuronitis, Bilateral, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Neuronitis, Vestibular Neuronitis, Bilateral, Vestibular Schwannoma
- What is being tested?
- gaze stabilization exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Dec 2004
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient had to have either a unilateral vestibular or bilateral vestibular hypofunction defined as follows: Unilateral vestibular deficits were defined by a > 25% difference in slow phase eye velocity between right and left sides on either the caloric or rotary chair test. Bilateral vestibular deficits were defined included refixation saccades made in response to unpredictable head thrusts to the right and left, a gain < .1 on rotary chair step test and a peak slow phase eye movement of <5 degrees/sec during irrigation of each ear on bithermal water caloric testing
- Healthy subjects with normal vestibular function test results
- must be able to complete DVA test
Who cannot join
- Patients with central lesions will be omitted from the study because vestibular adaptation or other compensatory mechanisms may be compromised and
- Patients with visual acuity when the head is stationary of 20/60 or worse.
- Patients on medication that suppress or facilitate vestibular function will not be excluded from the study but data will be analyzed to assess the effect of medication.
- Patient who do not understand the purpose of the study and what it involves
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Rehabilitation Medicine, Emory University
Atlanta, Georgia, 30322
About this study
Official title: Recovery of Visual Acuity in Vestibular Deficits
The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. We hypothesize that the performance of specific adaptation and substitution exercises will result in an improvement in visual acuity during head movements while those patients performing placebo exercises will show no improvement.
Read the detailed description
Decrements in visual acuity during head movement in patients with vestibular hypofunction are potentially serious problems. This deficit could contribute to decreased activity level, avoidance of driving with resultant diminished independence and, ultimately, limited social interactions and increased isolation. Oscillopsia occurs because of inadequate vestibulo-ocular reflex (VOR) gain and suggests that compensation for the vestibular loss has not occurred. The purpose of this study was to examine the effect of an exercise intervention on visual acuity during head movement in patients with unilateral and bilateral vestibular hypofunction. We hypothesized that 1) patients performing vestibular exercises would have improved visual acuity during head movement compared to patients performing placebo exercises; 2) there would be no correlation between dynamic visual acuity (DVA) and the patients' subjective complaints of oscillopsia; and 3) improvement in DVA would be reflected by changes in residual vestibular function as indicated by an increase in VOR gain.
Patients are assigned randomly to either the vestibular exercise or placebo exercise group. The randomization schedule is generated using a computer program for 2-sample randomization. The sequence was not concealed from the investigator who obtained consent from the subjects and supervised the exercises (SJH). The group assignment (vestibular exercise or placebo exercise) was concealed from the participants and from the investigator who performed the outcome measures.
The vestibular exercise group practiced exercises that consisted of adaptation exercises and eye-head exercises to targets (Table 1), which were designed to improve gaze stability 16. They also performed gait and balance exercises. The placebo exercise group performed exercises designed to be 'vestibular-neutral'.
- Being tested
- Control exercises, gaze stabilization exercises
- Keywords
- vestibular rehabilitation, vestibular hypofunction
- Medical subject headings
- Vestibular Neuronitis, Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control exercisesOther
saccadic eye movements against a plain background; no head movements
gaze stabilization exercisesOther
adaptation and substitutin exercises encorporating retinal lsip and head movements
| Study group | Role | What they receive |
|---|---|---|
| exercises for gaze stabilization | Experimental | Experimental group performed vestibular adaptation and substitution exercises Receives: Other: gaze stabilization exercises |
| Control exercises | Placebo comparator | Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements Receives: Other: Control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity During Head Movement From Baseline to Discharge
visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.
The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention).
Measured: pre-intervention and at discharge
Subjective Complaints: (All Pre- and Post-intervention):
questionnaire
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Secondary outcomes (6)
Disability Scale
questionnaire
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Activities Specific Balance Confidence Scale
questionnaire
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
visual analoque scales
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Balance and Gait
gait speed
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Fall Risk (Dynamic Gait Index)
performance test
Measured: pre-intervention, 2 weeks, 4 weeks and at discharge
Eye Movements: Scleral Search Coil
eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field
Measured: pre- and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startAug 2000
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vestibular NeuronitisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Susan Herdman, Emory University
- Investigators
- Susan J Herdman, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411216
- Sponsor's protocol ID
- IRB00000336
- Other IDs
- R01DC003196
- Status last verified
- Jul 2015
- First submitted
- 12 Dec 2006
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6.
PubMed 9831156Herdman SJ, Schubert MC, Tusa RJ. Role of central preprogramming in dynamic visual acuity with vestibular loss. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1205-10. doi: 10.1001/archotol.127.10.1205.
PubMed 11587600Schubert MC, Herdman SJ, Tusa RJ. Functional measure of gaze stability in patients with vestibular hypofunction. Ann N Y Acad Sci. 2001 Oct;942:490-1. doi: 10.1111/j.1749-6632.2001.tb03777.x. No abstract available.
PubMed 11710496Schubert MC, Herdman SJ, Tusa RJ. Vertical dynamic visual acuity in normal subjects and patients with vestibular hypofunction. Otol Neurotol. 2002 May;23(3):372-7. doi: 10.1097/00129492-200205000-00025.
PubMed 11981398Herdman SJ, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in unilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):819-24. doi: 10.1001/archotol.129.8.819.
PubMed 12925338Schubert MC, Das V, Tusa RJ, Herdman SJ. Cervico-ocular reflex in normal subjects and patients with unilateral vestibular hypofunction. Otol Neurotol. 2004 Jan;25(1):65-71. doi: 10.1097/00129492-200401000-00013.
PubMed 14724495Hall CD, Schubert MC, Herdman SJ. Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. Otol Neurotol. 2004 Sep;25(5):746-51. doi: 10.1097/00129492-200409000-00017.
PubMed 15354006Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.
PubMed 36809199Herdman SJ, Hall CD, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in bilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):383-9. doi: 10.1001/archotol.133.4.383.
PubMed 17438254
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Visual Acuity in Vestibular Deficits
- ClinicalTrials.gov ID
- NCT00411216
- Acronym / sponsor ID
- IRB00000336
- Keywords
- vestibular rehabilitation, vestibular hypofunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2000
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. We hypothesize that the performance of specific adaptation and substitution exercises will result in an improvement in visual acuity during head movements while those patients performing placebo exercises will show no improvement.
Detailed description
Decrements in visual acuity during head movement in patients with vestibular hypofunction are potentially serious problems. This deficit could contribute to decreased activity level, avoidance of driving with resultant diminished independence and, ultimately, limited social interactions and increased isolation. Oscillopsia occurs because of inadequate vestibulo-ocular reflex (VOR) gain and suggests that compensation for the vestibular loss has not occurred. The purpose of this study was to examine the effect of an exercise intervention on visual acuity during head movement in patients with unilateral and bilateral vestibular hypofunction. We hypothesized that 1) patients performing vestibular exercises would have improved visual acuity during head movement compared to patients performing placebo exercises; 2) there would be no correlation between dynamic visual acuity (DVA) and the patients' subjective complaints of oscillopsia; and 3) improvement in DVA would be reflected by changes in residual vestibular function as indicated by an increase in VOR gain.
Patients are assigned randomly to either the vestibular exercise or placebo exercise group. The randomization schedule is generated using a computer program for 2-sample randomization. The sequence was not concealed from the investigator who obtained consent from the subjects and supervised the exercises (SJH). The group assignment (vestibular exercise or placebo exercise) was concealed from the participants and from the investigator who performed the outcome measures.
The vestibular exercise group practiced exercises that consisted of adaptation exercises and eye-head exercises to targets (Table 1), which were designed to improve gaze stability 16. They also performed gait and balance exercises. The placebo exercise group performed exercises designed to be 'vestibular-neutral'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercises for gaze stabilization | Experimental | Other: gaze stabilization exercisesExperimental group performed vestibular adaptation and substitution exercises |
| Control exercises | Placebo comparator | Other: Control exercisesSaccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient had to have either a unilateral vestibular or bilateral vestibular hypofunction defined as follows: Unilateral vestibular deficits were defined by a > 25% difference in slow phase eye velocity between right and left sides on either the caloric or rotary chair test. Bilateral vestibular deficits were defined included refixation saccades made in response to unpredictable head thrusts to the right and left, a gain < .1 on rotary chair step test and a peak slow phase eye movement of <5 degrees/sec during irrigation of each ear on bithermal water caloric testing
- Healthy subjects with normal vestibular function test results
- must be able to complete DVA test
Key exclusion criteria (4 listed)
- Patients with central lesions will be omitted from the study because vestibular adaptation or other compensatory mechanisms may be compromised and
- Patients with visual acuity when the head is stationary of 20/60 or worse.
- Patients on medication that suppress or facilitate vestibular function will not be excluded from the study but data will be analyzed to assess the effect of medication.
- Patient who do not understand the purpose of the study and what it involves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control exercisessaccadic eye movements against a plain background; no head movements | Other | Control exercises |
| gaze stabilization exercisesadaptation and substitutin exercises encorporating retinal lsip and head movements | Other | exercises for gaze stabilization |
Primary outcome
Change in Visual Acuity During Head Movement From Baseline to Discharge
Time frame: pre-intervention and at discharge
visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second. The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention).
Subjective Complaints: (All Pre- and Post-intervention):
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
questionnaire
6 secondary outcomes
Disability Scale
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Activities Specific Balance Confidence Scale
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Balance and Gait
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Fall Risk (Dynamic Gait Index)
Time frame: pre-intervention, 2 weeks, 4 weeks and at discharge
Eye Movements: Scleral Search Coil
Time frame: pre- and post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 9831156Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6.
- Results publication: PubMed 11587600Herdman SJ, Schubert MC, Tusa RJ. Role of central preprogramming in dynamic visual acuity with vestibular loss. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1205-10. doi: 10.1001/archotol.127.10.1205.
- Results publication: PubMed 11710496Schubert MC, Herdman SJ, Tusa RJ. Functional measure of gaze stability in patients with vestibular hypofunction. Ann N Y Acad Sci. 2001 Oct;942:490-1. doi: 10.1111/j.1749-6632.2001.tb03777.x. No abstract available.
- Results publication: PubMed 11981398Schubert MC, Herdman SJ, Tusa RJ. Vertical dynamic visual acuity in normal subjects and patients with vestibular hypofunction. Otol Neurotol. 2002 May;23(3):372-7. doi: 10.1097/00129492-200205000-00025.
- Results publication: PubMed 12925338Herdman SJ, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in unilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2003 Aug;129(8):819-24. doi: 10.1001/archotol.129.8.819.
- Results publication: PubMed 14724495Schubert MC, Das V, Tusa RJ, Herdman SJ. Cervico-ocular reflex in normal subjects and patients with unilateral vestibular hypofunction. Otol Neurotol. 2004 Jan;25(1):65-71. doi: 10.1097/00129492-200401000-00013.
- Results publication: PubMed 15354006Hall CD, Schubert MC, Herdman SJ. Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. Otol Neurotol. 2004 Sep;25(5):746-51. doi: 10.1097/00129492-200409000-00017.
- Derived from this study: PubMed 36809199Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.
- Derived from this study: PubMed 17438254Herdman SJ, Hall CD, Schubert MC, Das VE, Tusa RJ. Recovery of dynamic visual acuity in bilateral vestibular hypofunction. Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):383-9. doi: 10.1001/archotol.133.4.383.
Related trials for Vestibular Neuronitis
Enrolling by invitation
Measuring Vestibular Organ Function With Weak Alternating Current Stimulation
Vestibular Disorder, Vestibular Schwannoma
Recruiting
Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
Vestibular Neuritis
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Herdman, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaze stabilization exercises in people with Vestibular Neuronitis and Vestibular Neuronitis, Bilateral, run by Emory University at 1 site in United States.
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 3 inclusion and 4 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 7 Aug 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Visual Acuity During Head Movement From Baseline to Discharge (time frame: pre-intervention and at discharge). The study lists 2 primary outcomes in all. 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 NCT00411216, which also lists 9 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 7 Aug 2015.