A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in gait parameters
研究概览
简要总结
This is a US-specific pilot study to evaluate the short- and long-term effects of the investigational MYNERVA Leia Sensory Prosthesis on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and to capture insights on the device's usability and perceived clinical effects.
详细描述
Through a single, two-hour in-person session per participant, this study is intended to generate preliminary evidence on whether the Leia Sensory Prosthesis improves gait patterns and sensory function in US adults with peripheral neuropathy, based on short-term device use.
A phone follow-up will inform on participant-reported clinical effects of the single use of Leia, and their duration.
Findings will also allow to gain a more comprehensive understanding of US demographic specifics to inform future device design, usability improvements, and potential adoption barriers ahead of further clinical development.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study procedure
- •Adults ≥ 18 years
- •Clinical diagnosis of peripheral neuropathy, confirmed per site procedures
- •Gait or balance difficulties as self-reported and confirmed by single-leg stance < 30 seconds
- •Able to walk without walking aids
- •Stable supplements and medications ≥ 1 month before intervention and willing to maintain stability during 1 month following the intervention
- •Willingness and ability to attend the initial in-person session (up to 2 hours) and follow-up calls.
排除标准
- •Untreated/unhealed lesions of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near device use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins)
- •Untreated/unhealed fractures in the foot and ankle
- •Cancerous growth in the planned treatment area
- •Severe peripheral vascular disease (e.g., gangrene)
- •Implanted electrical devices or pacemakers
- •Lower-limb orthoses/braces that cannot be removed for assessments
- •Pregnant or breast-feeding females
- •Usage of other medical devices for the relief of neuropathic symptoms during the study
- •Current participation in any other clinical study using an investigational device or investigational drug
- •Orthopedic conditions substantially limiting gait (e.g., failed back surgery syndrome (FBSS), recent hip or knee replacement, unstable fractures) as judged by the investigator
- •Inability to perceive the stimulation (tested by MYNERVA staff during calibration)
- •Cognitive impairment or poor command of English that preclude informed consent or answering questionnaires
研究组 & 干预措施
Leia Sensory Prosthesis
Participants use the device during a single supervised session at the clinic
干预措施: Leia Sensory Prosthesis (Device)
结局指标
主要结局
Change in gait parameters
时间窗: At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session
using the 10-meter walking test
次要结局
- Single-leg stance(At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session)
- Timed-up and Go (TUG) in seconds(At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) during the single 30 minutes treatment session)
- Sensory function - Monofilament test(At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session)
- Quality of life (NORFOLK QOL-DN (in part)(At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit))
- EQ-5D (in part) questionnaire(At visit 1 (Day 1) before the intervention, 1 day after intervention (visit 2), monthly up to max. 6 months (only if patients perceived persisting benefit))
- Neuropathic pain symptoms (NPSI questionnaire)(At visit 1 (Day 1) before the intervention and at visit 1 (Day 1) directly after the single 30 minutes treatment session)
- Patient history including symptoms, patient journey, and treatments received related to peripheral neuropathy(At visit 1 (Day 1))
- Fall history: fall questionnaire(At visit 1 (Day 1) before the intervention)
- Usability and patient satisfaction(At visit 1 (Day 1) directly after the single treatment session)
- Patient-reported perceived clinical effects after stimulation(1 day after intervention (visit 2), monthly until the effect is not persisting anymore or latest at 6 monts (whatever occurrs first))
- Safety Outcome(At visit 1 (Day 1) during the single 30 minutes treatment session until the maximal 6 months follow-up period ends)