RecruitingACTRN12623000444684

The effect of vestibular stimulation on postural control in people with bilateral vestibulopathy

The effect of noisy galvanic vestibular stimulation on postural control in people with bilateral vestibulopathy

Sponsor

Auckland University of Technology

Enrollment

31 participants

Start Date

Jun 14, 2024

Study Type

Interventional

Conditions

Bilateral vestibulopathy

Summary

Bilateral vestibulopathy (BVP) is a diagnosis where the neural signals that travel from the vestibular apparatus to the central nervous system are either absent or significantly reduced on both sides. This leads to imbalance, oscillopsia (visual blurring with head movement) and difficulty walking in darkness or over uneven surfaces. Vestibular hair cells and neurons do not regenerate, and there is currently no established remedial medical treatment for BVP once damage has occurred. An emerging treatment option is noisy galvanic vestibular stimulation (nGVS). A weak vestibular signal is boosted by a small nGVS signal, enhancing vestibular system performance, and improving balance. Most trials that have investigated the use of nGVS in people with BVP to date demonstrate positive, but varied, effects to improve postural instability in standing or walking. These studies are during a single session or two session trials. nGVS was a feasible adjunct to vestibular rehabilitation in further study, however, the efficacy of nGVS delivered as a rehab treatment is not yet established. This two-period randomised crossover trial will investigate whether people with bilateral vestibulopathy undertaking vestibular rehabilitation augmented with nGVS improve their postural stability more than vestibular rehabilitation with sham nGVS. We hypothesise that vestibular rehabilitation plus nGVS will result in improved postural control after four weeks of treatment compared to vestibular rehabilitation and sham stimulation.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Bilateral vestibulopathy (BVP) is a condition where both inner ears stop sending proper balance signals to the brain. This causes ongoing unsteadiness, blurry vision when moving your head, and difficulty walking on uneven ground or in the dark. There is no cure, and traditional rehabilitation exercises can only do so much. This trial is testing a technique called noisy galvanic vestibular stimulation (nGVS) — a gentle electrical signal delivered through small electrodes placed behind the ears. The idea is that this mild stimulation can amplify the weak signals the inner ears are still producing, helping the brain better detect movement. Participants will receive vestibular rehabilitation exercises combined with either real nGVS or a sham (inactive) device, in a crossover design where everyone eventually receives both. You may be eligible if you have a probable diagnosis of BVP confirmed by a specialist, experience unsteadiness when walking, and are aged 18–80. You are not eligible if you have a pacemaker, cochlear implant, or certain other metal implants in the head or neck.

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Interventions

Vestibular rehabilitation plus noisy galvanic vestibular stimulation (nGVS) Vestibular rehabilitation will be for 45 minutes twice a week for 4 weeks and carried out in face to face treatments by a r

Vestibular rehabilitation plus noisy galvanic vestibular stimulation (nGVS) Vestibular rehabilitation will be for 45 minutes twice a week for 4 weeks and carried out in face to face treatments by a registered Physiotherapist. Vestibular rehabilitation will include exercises promoting: • Vestibular adaptation (strengthening residual vestibular afferent information) eg. Visual fixation on an object while moving head (x1 exercise), Visual fixation on moving object with head moving in opposite direction (x2 exercise) • Vestibular substitution (strengthening compensatory strategies) eg. Active eye and head movements between stationary targets, imaginary visual fixation with eyes closed, neck proprioception cueing • Balance and gait exercises eg. Multisensory balance training, training limits of stability, task specific training with modification of sensory inputs (vestibular, visual, somatosensory) • Reversing the effects of detraining/ sedentary lifestyle eg. Walking, stationary cycling, stationary rowing During 30 minutes of the vestibular rehabilitation participants will receive nGVS applied at parameters that have been shown to optimise the participant's postural control during an assessment prior to the clinical study. Machine: DC stimulator mobile electrodes: 5cm x 5cm carbon rubber electrode skin interface: saline soaked sponge Waveform: Gaussian white noise Frequency band: either 0.01- 10 or 0-30 depending on participant responsiveness Amplitude: the subthreshold amplitude that improves lateral gait variability the most. Adherence will be measured by participant attendance sheets In this crossover trial there is a 12 week washout period between treatment periods The order of treatment will be determined by random number generator. 50% of participants will receive the intervention treatment first, 50% of participants will receive the control treatment first.

Locations(1)

Auckland, New Zealand

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ACTRN12623000444684