Vestibular impairment in people with multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Interventional study (trial 1):
Participants identified with either a peripheral or central vestibular impairment will be entered into the randomised controlled trial (RCT) and randomly allocated to e
Sponsors
Plymouth University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of MS according to revised McDonald criteria 2. Patient determined disease steps 1-5, equivalent to Expanded Disability Status Scale (EDSS) 2-6.5 3. Reporting one of the following at least 4 times per month (questions 1, 7 and 18 on the Vertigo Symptom Scale (VSS)): 3.1. Feeling that things are spinning or moving around 3.2. Feeling of being light-headed, “swimmy” or giddy 3.3. Feeling unsteady and about to lose balance 4. Aged 18 years or older 5. Willing and able to travel to and participate in the 12 face to face sessions should they be allocated to the customised face to face treatment group of the randomised controlled trial, and to commit to undertaking their individualised home-based programme 6. Willing and able to travel to local assessment centres for blinded outcomes assessment People will be firstly screened for the presence of BPPV. Those with BPPV will be entered into the observational trial (trial 2). The remaining participants will be screened for the presence of central or peripheral vestibulopathy. Those with central and/or peripheral vestibulopathy will be entered into the randomised controlled trial (trial 1).
Exclusion criteria
Exclusion criteria: 1. Neurological conditions other than MS as determined from clinical notes 2. Relapsed/received steroid treatment within the last month 3. Currently or recently (within past six months) participated in a VR Program 4. Orthopaedic deficit which may on impact on postural and gait testing or significant pain or weakness (> 4/10 on a numerical rating scale) associated with osteo- or rheumatoid arthritis 5. Dizziness solely explained by other causes (e.g. postural hypotension) 6. Headache or migraine associated with a subjective report of one of the following at least 4 times per month: 6.1. Nausea (feeling sick) or stomach churning 6.2. Vomiting 7. People who have been taking vestibular sedatives specifically for the treatment of vertigo for more than 4 weeks. Vestibular sedatives impair the vestibular compensation process that occurs with rehabilitation (53). Therefore we will ask people on vestibular sedatives to stop their medication for the testing and trial. We will inform people’s GP and neurologist about this advice. Medications such as prochlorprazine can also reduce migraines and so there can be a rebound migraine when such medications are withdrawn following chronic use (> 1 month). Therefore people who have been taking vestibular sedatives for more than 1 month will be excluded. If people have been chronically taking vestibular sedatives (> 1 month) and, with approval of their neurologist and/or GP they stop the medication then they will be eligible to take part in the study after a 6 week wash out period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure for trial 1 (interventional study): Impact of dizziness on daily life (functionally, emotionally and physically), assessed using the Dizziness Handicap Inventory (DHI) questionnaire at the baseline, after 14 weeks and after 26 weeks Primary outcome measure for trial 2 (observational study): Presence of BPPV as assessed using the Dix-Hallpike test and the log roll test at the baseline, after one week and after 26 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures for trial 1 (interventional study) -t he following will be assessed at the baseline, after 14 weeks and after 26 weeks unless otherwise stated: 1. Impact of multiple sclerosis (MS) on walking using the 12-item Multiple Sclerosis Walking Scale (MSWS-12) 2. Perceived confidence in performing 16 activities of daily living, assessed using the Activities-Specific Balance Confidence (ABC) scale 3. Symptoms of poor balance and increased anxiety and arousal as a result of vertigo, assessed using the Vertigo Symptom Scale (short form) (VSS) 4. Visually induced dizziness symptoms, assessed using the Situational Characteristic Questionnaire 5. MS-specific health-related quality of life, assessed using the 29-item Multiple Sclerosis Impact Scale (MSIS-29) Version 2.0 6. MS-specific fatigue, assessed using the Fatigue Scale for Motor and Cognitive functions (FSMC) 7. Depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) 8. Health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), assessed using the EQ-5D-5L 9. Falls over the past month, assessed using a retrospective diary at the baseline 10. Prospective falls over 12 weeks, assessed using a prospective falls diary at assessment 2 and follow-up 11. Functional walking, assessed using the Dynamic Gait Index (DGI) 12. Vestibulo-ocular reflex function: 12.1. Visual acuity assessed using the Freiburg Visual Acuity Test (FrACT) Landolt C protocol 12.2. Dynamic visual acuity assessed by passively moving the head back and forth through a 400 arc in a horizontal plane at a frequency of approximately 1.5 Hz 13. Visual dependency, assessed using a Rod and Disc test involving participants determining their subjective visual vertical by indicating when a luminous rod is vertical either in darkness or when it is placed in front of a patterned disc rotating in the frontal plane (laptop version) 14. Cognitive impairment and processing speed, assess | — |
Countries
England, United Kingdom
Contacts
Public Contactjonathan Marsden
Outcome results
None listed