DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Motor Assessment
研究概览
简要总结
Our goal is to temporarily implant the following groups for 540 +/- 30 days:
-
Forearm FAST electrodes
-
Five human partial hand amputees (amputated at the level of the hand) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve.
-
Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve .
-
Arm FAST electrodes
-
Five human partial hand amputees (amputated at the level of the hand) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve.
-
Five human hand and forearm amputees (amputated at the level of the forearm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve.
-
Five human hand, forearm and arm amputees (amputated at the level of the arm) with 2 FAST electrodes in the ulnar nerve and 2-5 FAST electrodes in the median nerve.
详细描述
Study Procedures:
Subjects will be consented during a pre-operative visit in the Plastic Surgery Clinic and screened for participation.
Screening history and physical Potential human subjects will receive a full medical assessment by the PI. The screening interview will focus on details of the patient's upper extremity condition and comprehensive details of the patient's overall health status. The screening examination will include general examination of the subject.
Pre-operative imaging and diagnostic studies MRI, x-ray, EMG/Nerve conduction studies (NCS) - Each subject who passes the screening H&P will receive the following for their residual limb: magnetic resonance neurogram (MRN), plain x-rays, EMG/nerve conduction studies, and psychological assessment. Other studies will be performed in accordance with the UT (University of Texas) Southwestern pre-operative testing protocol, and will depend on the age/gender/medical history of the subject.
MR neurogram will provide information regarding the location and health of amputated peripheral nerve stumps in the residual limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overall and phantom pain are well-controlled and not incapacitating
- •Criteria for Exclusion of Subjects:
- •If MR neurogram and EMG/NCS study show nerve or muscle dysfunction/injury at a higher level than anticipated based on the appearance of the physical amputation stump, the subject may be excluded from the study due to adverse neuromuscular anatomy which would preclude use of the proposed experimental electrode implants. The radiographs will be used to confirm suitability of the amputation stump configuration. If the bony anatomy of the amputation stump is found to be unsuitable, the patient may be excluded from the study.
- •Subjects who have a history of cardiac arrhythmia will be excluded from the study.
排除标准
- 未提供
研究组 & 干预措施
Fast electrodes
Implant temporary Fast electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.
干预措施: Fast electrode (Other)
结局指标
主要结局
Motor Assessment
时间窗: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
We will ask you to attempt to perform hand movements and positions. The movement trials will consist of simultaneous volitional movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb done. This allows us to have a physical record of exactly what movement is being attempted by the amputated limb. We will record nerve and muscle electrode activity during all of the movement trials. During some movement trials, we will stimulate the LIFE neural electrodes while recording from implanted vs. surface adhesive vs. percutaneous needle muscle electrodes
Sensory Assessment
时间窗: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
We will also perform sensory detection and discrimination trials. Here, you will be asked to report if you detect any sensation during microstimulation (delivering very small electrical signals) via LIFE electrodes. If you do have a sensory perception, you will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. You may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Other stimulation trials that may be done will include single or multiple electrode stimulation to see if subjects can perceive multiple sensory percepts simultaneously. Blinded trials may be done to determine if the subjects are actually perceiving the same percept for a given stimulation paradigm. Other trials may include modulating the stimulation parameters to determine if the sensory percept changes characteristics with varying stimulation paradigms.
Sensory-Motor Integration
时间窗: up to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
After determining your sensory detection and discrimination parameters, we will ask you to repeat standardized assessments using the existing myoelectric partial hand prosthesis. Microstimulation via LIFE electrodes will be paired with motion or contact during task performance in order to determine whether providing evokes sensation during prosthesis use improves task-based performance.
次要结局
未报告次要终点
研究者
Jonathan Cheng
Associate Professor
University of Texas Southwestern Medical Center