None listed
Conditions
Brief summary
Transcutanous vagus nerve stimulation (taVNS) is an emerging non-invasive neuromodulation therapy which aims to modulate brain activity through electrical stimulation of a small branch of the vagus nerve located in the auricle. Recently, taVNS paired with rehabilitation has been shown to be a feasible and safe approach to improve upper-limb weakness in subacute and chronic stroke when combined with physical rehabilitation. The positive effect of taVNS on upper-limb motor function, likely driven by enhanced neuroplasticity suggests that pairing taVNS with physical rehabilitation might prove beneficial for enhancing other motor impairments after stroke. This research aims to assess the feasibility, safety, and preliminary efficacy of taVNS paired with rehabilitation for enhancing gait and balance after stroke (> 6 months).
Interventions
Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied using tVNS® R device (tVNSTechnologies GmbH, Reichenschwand, Germany) by a researcher who is a physiotherapist. Stimulation intensity will be individually adjusted to a level that is above the individual’s sensory threshold and below pain threshold (a tolerable stimulus). Participants will be allocated to one of two groups, active stimulation stream or sham stimulation stream. In addition, both groups will receive physical
Transcutaneous auricular vagus nerve stimulation (taVNS) will be applied using tVNS® R device (tVNSTechnologies GmbH, Reichenschwand, Germany) by a researcher who is a physiotherapist. Stimulation intensity will be individually adjusted to a level that is above the individual’s sensory threshold and below pain threshold (a tolerable stimulus). Participants will be allocated to one of two groups, active stimulation stream or sham stimulation stream. In addition, both groups will receive physical rehabilitation therapy concurrently with the taVNS active or sham stimulation. taVNS will be applied at every rehabilitation session. Physiotherapy intervention will be based on Stroke Foundation Clinical Guidelines (Australia) for Stroke Management. The following framework is based on motor learning principles and will be tailored to individuals’ impairments, rehabilitation goals, and level of mobility. Sessions can include the following components: 1) goal-oriented task-specific training (for example practice of walking components followed by practice of walking on land or on a treadmill, and balance training in sitting and in standing position), 2) aerobic exercise (for example, bicycle ergometer, walking on a treadmill or on land), and 3) core and lower limbs strengthening exercises. Each participant will receive 15 therapy sessions conducted over 6 weeks (2-3 x 1-hour sessions per week). This will be provided on a one-on-one basis by a qualified physiotherapist. All sessions will be conducted within the City West Health and Medical Clinic of the University of South Australia, Adelaide, Australia. Stimulation parameters for active taVNS group will be as follow: electrode will be placed at cymba concha of the left ear. A pulse width of 0.3 ms, a frequency of 25 Hz, and a pulse pause ratio of 30 sec on: 30 sec off will be used. The stimulation will be delivered for up to 1 hour concurrent with physical rehabilitation. Adherence to intervention will be monitored by auditing participants’ attendance checklist as well as details of physical rehabilitation intervention and stimulation parameters provided which will be documented in participants’ medical records.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older; first-ever haemorrhagic or ischaemic stroke at least 6 months earlier; can walk 10 meters with or without a gait aid and with or without assistance, no history of other neurological conditions; gait and/or balance impairment; ability to give informed consent and to understand instruction.
Exclusion criteria
Previous vagus nerve surgery; cognitive impairment and/or language impairment that might impact the person's ability to consent or understand instructions (MOCA score of less than 18) ; severe pain in any joints of the affected limb; advanced cardiac, pulmonary, kidney or liver condition; pregnancy; active implants; cerebral shunts; open skin at the point of stimulation.
Outcome results
None listed