Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT04947462
- Status
- Recruiting
Conditions
- Upper Limb Amputees
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Chronically Implanted Neural and Muscular Interface — DEVICEParticipants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).
Study Details
The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.
Key Dates
- Start date
- Dec 1, 2021
- Status verified
- May 2026
- Primary completion
- May 31, 2030
- Completion
- May 31, 2030
Study Design
- Enrollment
- 8 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: Chronically Implanted Neural and Muscular Interface8 eligible participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).
Primary Outcome Measure
Magnitude of change in perceived joint position [ Time Frame: This metric will be measured approximately each month for two years. ]
Central Contacts
- Emily L Graczyk, PhD(216) 791-3800
- Jessica R Jarvela, MS BS(216) 791-3800
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | Emily L Graczyk, PhD (PRINCIPAL_INVESTIGATOR) |