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| ID | Type | Description | Link |
|---|---|---|---|
| 1583890 | Other Identifier | IRBnet | |
| RD001968-01A1 | Other Grant/Funding Number | VA Rehabilitation R&D |
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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with above and below the knee limb loss. The investigators will implanted stimulating electrodes to send small electrical currents to the remaining nerves. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how the information about your foot and lower limb used to be transferred to the brain prior to your limb loss. Additionally, there is the option to have muscle recording electrodes implanted within the muscles of the lower limb with the goal to develop a motor controller that would allow the user to have intuitive control of a robotic prosthetic leg.
Electrodes are surgically implanted on one to four nerves of the residual limb. Intramuscular recording electrodes can be implanted in the lower limbs and hip muscles in order to obtain electromyography (EMG) signals. The EMG recordings will be used to develop an algorithm which can operate an advanced robotic prosthesis in which the prosthesis joint(s) movements could be controlled. An external wearable stimulation device controls the delivery of electrical pulses to the implanted system. An instrumented prosthesis will be developed such that perceived sensations would correspond to prosthesis interactions with the floor. The instrumented prosthesis 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi contact electrode implant and implanted electromyography recording electrodes | Experimental | Fifteen subjects with lower limb amputation will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary percutaneous leads. During experimental testing, a small amount of stimulation will be applied to the nerves through the contacts of the multichannel cuff electrode. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode | Device | See arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| Stimulation thresholds | Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb. | 9 months post implant |
| Functional Gait Assessment (FGA) | 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. | 6 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Syndrome Inventory (NPSI) | The NPSI is comprised of five subscales, each representing different dimensions of neuropathic pain: burning spontaneous pain (burning), pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia Each area subscale is scored between 0-10. The scores are not combined, but are able to report on different aspects of neuropathic pain. A higher score indicates a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald Triolo, PhD | Contact | (216) 791-3800 | ronald.triolo@va.gov | |
| Aarika Sheehan, DPT | Contact | (216) 791-3800 | 65832 | Aarika.Sheehan@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ronald Triolo, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Recruiting | Cleveland | Ohio | 44106-1702 | United States |
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| Label | URL |
|---|---|
| VA Center of Excellence website listing this and other ongoing studies. | View source |
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Deidentified data will be provided upon request.
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The project will take the form of a series of controlled single-subject feasibility and proof-of-concept studies with repeated measures. Subjects will act as their own concurrent controls with and without sensory stimulation, as well as their own longitudinal (historical) controls pre- and post-implementation of the Sensory Neuroprosthesis.
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| 4 years post implant |