NCT07536022尚未招募不适用
Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
研究概览
简要总结
The goal of this clinical trial is to learn if taVNS works to treat symptoms of Parkinson's Disease in adults. It will also learn about the feasibility and preliminary efficacy of taVNS administered at home by the participant.
The main questions it aims to answer are:
- Is at-home taVNS feasible and effective for treating symptoms of Parkinson's Disease? How often are participants completing the stimulation protocol? What are the side effects of stimulation experienced by participants? How do participants rate the experience of taVNS sessions at home? How do participants' scores on assessments and questionnaires change with taVNS treatments?
- How does taVNS impact connections between neural networks in the brain of patients with Parkinson's Disease at rest?
Participants will:
- Have a baseline MRI scan to take images of their brain.
- Complete a series of assessments and questionnaires to evaluate their Parkinson's Disease motor symptoms, cognitive and neuropsychiatric symptoms, and other non-motor symptoms.
- Have an initial taVNS session where their threshold to perceive the stimulation will be measured. This value will be used to stimulate each participant at a specific dose relative to their individual perception of stimulation.
- Be trained on how to use the taVNS device and system and have one 1-hour taVNS session where their vitals will be monitored.
- Self-administer 1-hour daily taVNS sessions for 8 weeks at-home, complete tolerability questionnaires, and weekly remote check-ins with study staff.
- After 4-weeks of at-home taVNS, participants will come in-person to repeat the questionnaires and assessments from the first visit.
- Following the 8 weeks of taVNS sessions, participants will repeat the MRI scan, assessments and questionnaires from visit 1.
- Participants will complete questionnaires remotely 1 month following their last taVNS sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Issues with walking, balance, and gait as determined by a movement disorders neurologist (a score of equal to or greater than 1 on MDS-UPDRS items 2.12 (walking and balance), and 3.10 (gait))
- •Diagnosis of idiopathic Parkinson's Disease based on UK Brain Bank diagnostic criteria
- •Hoehn and Yahr Stage 2-4 as determined by a movement disorders neurologist
- •Stable on dopaminergic medications over the past 30 days prior to enrollment in the study
排除标准
- •A history of taVNS in the last 6 months
- •A history of brain surgery, traumatic brain injury or stroke
- •Diagnosis of a nervous system disorder besides PD, alcohol or substance use disorder, or unstable cardiovascular conditions
- •History of myocardial infarction or arrhythmia, bradycardia
- •A history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
- •Inability to complete gait/ motor assessments (without assistance or assistance devices)
- •Ear trauma, facial pain, anatomical abnormalities or other barriers preventing earpiece fit
- •Failure to meet all criteria on a standardized MRI/taVNS safety screening: This includes, but is not limited to, the presence of claustrophobia, implanted electronic devices that are not 3T MRI compatible (e.g., pacemakers), metallic objects or fragments (e.g., bullets), and non-removable hair clips or piercings.
- •Individuals with a diagnosis of cognitive impairment (MoCA < 24) that would make them unable to understand and follow study instructions or to consent for themselves.
- •Pregnancy
- •Visual hallucinations or other psychotic symptoms, other than mild visual hallucinations secondary to PD medications, not requiring treatment, or well controlled on stable doses of quetiapine or pimavenserin.
- •Individuals with a history of seizure(s)
- •Inability to perform at-home taVNS procedures safely and properly (either alone or with the aid of a caregiver)
- •Uncorrected visual or hearing impairments that would impact performance on cognitive tests or ability to follow study procedures
- •Use of B-Blockers, dopamine blocking agent (other than quetiapine or pimavenserin in stable doses), antiarrhythmic medication, acetylcholine esterase inhibitor (study doctor will consider if on stable doses), midodrine, fludrocortisone, droxidopa, or anticholinergic drugs
研究组 & 干预措施
taVNS Stimulation
Experimental
one in-person taVNS session followed by 8 weeks of at-home taVNS sessions
干预措施: transcutaneous auricular nerve stimulation (Device)
结局指标
主要结局
Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
时间窗: Baseline to end of 8-week at-home taVNS intervention
Adherence defined as the percentage of prescribed daily taVNS sessions completed over the 8-week intervention period, measured using automated device usage logs from the Sparrow Link Hub and mobile application.
Change in Parkinson's Disease Motor Symptoms Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
时间窗: Baseline, Week 4, and Week 8
Change in motor symptom severity measured using the MDS-UPDRS Part III. Total score range: 0-132, with higher scores indicating worse motor impairment
次要结局
- Change in Spatiotemporal Gait Parameters(Baseline, Week 4, Week 8, and 1-month follow-up)
研究者
研究点 (1)
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