Parkinson’s disease Nervous System Diseases Parkinson disease
Conditions
Interventions
Participants will be asked to visit the research gait laboratory on three occasions separated by 12 weeks (for a total duration study duration of 24 weeks). All assessments will take place at the Clin
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Parkinson’s disease, as defined by the UK Brain Bank Criteria 2. Hoehn and Yahr stage I – III 3. Stable medication for preceding one month and anticipated over next 3 months 4. Able to walk independently without aid for a minimum of 2 minutes without rest 5. Able to provide informed consent 6. Aged <75 years
Exclusion criteria
Exclusion criteria: 1. Parkinson’s disease dementia or significant cognitive impairment (Montreal Cognitive Assessment (MoCA) score 160 mmHg, diastolic >100 mmHg) after three measurements within 24 hours 14. Has had a previous unilateral or bilateral vagotomy 15. Has been implanted with metal cervical spine hardware, other metallic implants or implantable medical device (such as a deep brain stimulator, hearing aid implant, pacemaker, implantable cardioverter defibrillator, cranial aneurysm and/or cranial aneurysm clips, history of facial/orbital/metallic fragments, implanted electronic device, neurostimulator, valve replacements/stents, metallic implants/prostheses) near the stimulation site (such as stent, bone plate or bone screw) 16. History of syncope or seizures (within the last 2 years) 17. Patients with an active cancer or are in recent remission of cancer 18. Clinically significant hypotension, bradycardia or tachycardia 19. Known carotid atherosclerosis 20. Insufficient comprehension of the English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Intervention safety measured by recording adverse events using self-reports and clinical judgment of the Chief investigator with interim phone calls at 4 and 8 weeks and at 12 weeks. 2. Process indicators of the study: recruitment and randomisation rates defined by: 2.1. Proportion of eligible patients who consent to participate in the trial at baseline 2.2. Proportion of enrolled patients who successfully complete follow-up at 12 and 24 weeks 3. Acceptability of study design including attendance rates, completion of nVNS, experience of intervention, retention and reasons for drop-outs, suitability of the intervention package, as assessed by questionnaires at 12 weeks 4. Tolerability of multi-dose nVNS measured using self-reported compliance with interim phone calls at 4 and 8 weeks and at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in gait measured using an instrumented walkway and body-worn sensors at 12 and 24 weeks 2. Change in macrostructural gait characteristics including volume, variability, pattern of walking bouts and steps measured using body-worn sensors and 7-day free-living monitoring at 12 and 24 weeks 3. Change in attention and fluctuating attention measured using the simple reaction time (SRT), choice reaction time (CRT) and digit vigilance (DV) tasks (fluctuating attention is determined by the coefficient of variance of the three tasks) at 12 and 24 weeks 4. Change in executive function measured using the One Touch Stockings of Cambridge (OTS) from the Cambridge Neuropsychological Test Automated Battery (CANTAB) computerised battery at 12 and 24 weeks 5. Change in memory measured using the Paired Associates Learning (PAL) from CANTAB at 12 and 24 weeks 6. The number of falls, fall rate and time to first fall measured prospectively using standardised falls diaries during the 12-week intervention period 7. Change in autonomic function and heart-rate variability components measured using a cardiac monitor at 12 and 24 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed