ISRCTN19394828进行中（未招募）未知
Adjunctive vagus nerve stimulation for improving neural control of gait in Parkinson’s disease
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2021年8月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36737716/ (added 06/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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