Feasibility of Neural Feedback for Lower Limb Amputees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Stimulation Thresholds
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.
Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.
详细描述
Electrodes are surgically implanted on one to four nerves of the residual limb. An external wearable device controls the delivery of electrical pulses to the implanted system. The participant will be asked to verbally describe the perceived sensations and highlight their locations on a drawing of a foot presented to them on an electronic screen. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. This instrumented prosthesis, also known as a sensory neuroprosthesis, will be worn while the participant is engaging in various functional tasks, such as standing, walking, or climbing stairs, or with visual or mental distractions.
Intramuscular recording electrodes can be implanted in the lower limb(s) and/or hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings from the residual muscles will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the movement of the joint(s) could be controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adults age 18 or greater
- •Chronic, medically stable ( > 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.
- •Potential user of trans-tibial or trans-femoral prostheses for standing or walking
- •Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like
- •Good skin integrity and personal hygiene
- •Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
- •Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule
排除标准
- •Uncontrolled diabetes to a degree that would preclude surgery
- •Significant vascular disease
- •Chronic skin ulcerations
- •Significant history of poor wound healing
- •Significant history of uncontrolled infections
- •Active infection
- •Significant pain in the residual or phantom limb
- •Pregnancy
- •Inability to speak English
- •Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
- •Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
- •Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- •Poor surgical candidate
- •Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.
研究组 & 干预措施
Stimulating nerve electrodes & intramuscular recording electrodes
Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads.
During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes.
Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.
干预措施: Stimulating nerve electrodes and intramuscular recording electrodes (Device)
结局指标
主要结局
Stimulation Thresholds
时间窗: 9 months post implant
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
Functional Gait Assessment (FGA)
时间窗: 1 year post implant
The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.
次要结局
未报告次要终点
研究者
Ronald Triolo
Senior Research Career Scientist, US Department of Veterans Affairs,
Louis Stokes VA Medical Center