Improving neural control of gait in Parkinson's disease
Research type
Research Study
Full title
Adjunctive Vagus Nerve Stimulation for Improving Neural control of Gait in Parkinson’s Disease
IRAS ID
292216
Contact name
Alison Yarnall
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN19394828
Duration of Study in the UK
2 years, 1 months, 26 days
Research summary
Research has shown that there is a loss of chemicals other than dopamine in the brain in people with Parkinson’s (PwP), such as acetylcholine. Acetylcholine has been shown in imaging and nerve studies to play important roles in memory, thinking and walking. This is important, as changes in the way PwP walk can increase risk of falling. We are interested in a new treatment known as non-invasive vagus nerve stimulation (nVNS). This uses a small handheld device placed on the neck to stimulate a nerve called the vagus nerve. By stimulating the vagus nerve we may increase the amount of acetylcholine available in the brain. We have shown in a small study that single dose nVNS may improve walking in PwP. We are now looking to verify these findings and to check this treatment is acceptable to PwP. 40 PwP will undergo memory tests, a walking test and other assessments. Participants will be randomly split to receive either the ‘active’ or ‘placebo’ treatment. The participant will be shown how to use the device to deliver the stimulation to the neck for two minutes, and be asked to use the device at home twice a day for two minutes for 12 weeks. At 12 weeks we will repeat the baseline measurements and compare the active and placebo groups. We will also ask about PwP’s experience of using the device. We will ask some participants to take part in a focus group discussion to help plan a further trial. We will repeat most of the assessments again at 24 weeks, after participants have stopped using the device, to see if there are carry-over effects of the intervention.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0177
Date of REC Opinion
26 Aug 2021
REC opinion
Further Information Favourable Opinion