Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Demonstrate Superiority
研究概览
简要总结
The goal of this clinical trial is to learn if the cueStim device can reduce the duration of freezing of gait (FoG) that occurs in patients with Parkinson's Disease. The study will compare two modes of operation of the cueStim device; both modes of operation use the same wearable device. The purpose of the study is to compare how the two modes affect symptoms across study participants. Because this is a research study, it is not yet known whether either mode reduces symptoms.
Participants will:
- Be randomized to one of the two modes available on the cueStim device
- Wear the device for 4 weeks as they go about their daily life
- Complete daily diary entries to document symptoms, falls and overall experience
- Check-in with the clinical site throughout participation
- Complete a final follow-up visit
详细描述
This is a prospective, randomized, double-blind, parallel group, multicenter, pivotal clinical trial to validate the use of cueStim for reduction of duration of FoG in Parkinson's patients.
Enrolled subjects will be randomized 1:1 to two different modes of treatment. All subjects will be blinded to the study hypothesis. The clinician will not be blinded; however, specialists who will evaluate the outcome will be blinded. Enrolled subjects will be provided with training on the device during a clinic visit, and phone support is available throughout the home treatment duration.
Study procedures / visits consists of:
- In-clinic Screening visit to ensure eligibility
- Baseline visit for device setup and training (may be combined with screening visit)
- "Home" (unsupervised at and out of the home) use of the device for four (4) weeks) as the patient goes about their daily life
- End-of-treatment Follow-up visit
The primary objective of this clinical investigation is to determine if one mode of treatment demonstrates superiority after four weeks of device use, in reducing the duration of FoG, while the device is being worn by patients with PD receiving medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Enrolled subjects will be randomized 1:1 to two different modes of treatment. All subjects will be blinded to the study hypothesis. The clinician will not be blinded; however, specialists who will evaluate the outcome will be blinded.
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-90 years, inclusive
- •Diagnosis of idiopathic PD, confirmed by a neurologist/Medical Doctor (MD), medical records, and verified during a post consent in-clinic evaluation by a trained MD
- •Patients can walk 12 meters without a walking aid (cane permitted during daily life)
- •The patient is using levodopa treatment. PD medications are stable, with no changes in PD-related medications for at least four weeks prior to screening visit, and stable dosing expected for duration of the study
- •Score greater or equal to 22 on the Montreal Cognitive Assessment (MoCA)
- •Satisfactory standard neurological examination, including completion of MDS- UPDRS I, II, III and IV by study clinician
- •PTF ≥20% during the baseline in-clinic FoG Provocation Test (conducted without the device) as determined by the centralized blinded video analysis using the FoG Switch tool by trained personnel independent of site investigators.
排除标准
- •Atypical or secondary parkinsonism, including vascular parkinsonism
- •History of dementia, severe depression, psychosis, or active hallucinations
- •History of migraines, tinnitus, seizures or sensory issues
- •Other neurological or orthopedic impairment significantly affecting gait
- •Previous use of cueing devices within the last 3 months
- •Use of implanted electronic devices, including deep brain stimulation (DBS)
- •Use of assistive devices incompatible with the device (DBS users will be excluded
- •Is participating in another clinical trial during the study period
- •Any condition that, in the investigator's opinion, makes the participant unsuitable
- •As per medical records, any of the following identified within 3 months: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft, percutaneous coronary intervention, implantation or use of a cardiac resynchronization therapy device, active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse.
- •Pregnant or breastfeeding women
结局指标
主要结局
Demonstrate Superiority
时间窗: From enrollment to the end of treatment at 4 weeks
The main goal of this study is to determine whether one mode of the cueStim device works better than another. After four weeks of use, it will be compared how well each mode reduces the duration of freezing of gait in patients with Parkinson's Disease who are taking medication, while they are wearing the device.
次要结局
未报告次要终点