Improving neural control of gait in Parkinson's disease

Not Applicable

• Conditions: Parkinson’s disease; Nervous System Diseases; Parkinson disease

• Registration Number: ISRCTN19394828
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36737716/ (added 06/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 9 October 2023
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

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

1. Parkinson’s disease dementia or significant cognitive impairment (Montreal Cognitive Assessment (MoCA) score <21)
2. History of stroke, traumatic brain injury, intracranial aneurysm, intracranial haemorrhage, brain tumour or atypical parkinsonian disorder
3. Unstable medical condition in the last 6 months, or planned surgeries that may involve implants within the next 6 months
4. Prescribed centrally acting anticholinergics (e.g., amitriptyline) and cholinesterase inhibitors
5. Severe orthopaedic or neurological (excluding Parkinson’s disease) pathology that will adversely affect gait
6. Pain at the nVNS treatment site (e.g. dysaesthesia, neuralgia, cervicalgia)
7. Previous use of nVNS stimulator device, including previous participation in nVNS research
8. Women of child-bearing potential or who are pregnant
9. Active participation in another interventional trial or exposure to an experimental drug or intervention
10. Has a lesion (including lymphadenopathy), previous surgery (including carotid endarterectomy or vascular neck surgery) or abnormal anatomy at the treatment site (open wound, rash, infection, swelling, cut, sore, drug patch, surgical scar[s])
11. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or stroke), congestive heart failure (CHF), known severe coronary artery disease or prior myocardial infarction
12. Abnormal baseline electrocardiogram (ECG) within the last year (e.g. second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
13. Uncontrolled high blood pressure (systolic >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 2. Process indicators of the study: recruitment and randomisation rates defined by:<br> 2.1. Proportion of eligible patients who consent to participate in the trial at baseline<br> 2.2. Proportion of enrolled patients who successfully complete follow-up at 12 and 24 weeks<br> 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<br> 4. Tolerability of multi-dose nVNS measured using self-reported compliance with interim phone calls at 4 and 8 weeks and at 12 weeks<br>