Clinical trial NCT04430218: Peripheral Interfaces in Amputees for Sensorimotor Integration
Official title: Peripheral Interfaces in Amputees for Sensorimotor Integration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Extremity Amputee
Keywords: Sensory Feedback
Advanced Control
Sensorimotor feedback
Prostheses and implants
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: Congressionally Directed Medical Research Programs
First posted: 2020-06-12
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
Primary purpose: OTHER

Brief summary: The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

Detailed description: The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.

Eligibility criteria: Inclusion Criteria:

* Age 21 or greater
* Acquired upper limb amputation
* Unilateral or bilateral amputation, Above or below elbow
* At least 6 months since time of amputation
* Current user of a myoelectric prosthesis or prescribed to use one
* Viable target nerves in the upper extremity \*
* Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities

Exclusion Criteria:

* A contraindication preventing surgery
* Uncontrolled diabetes
* Chronic skin ulcerations
* History of poor wound healing without specific cause
* History of uncontrolled infection without specific cause
* Active infection
* Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
* Inability to speak English
* Expectation that MRI will be required at any point for duration of study or while device is implanted.
* Arthritis in the area of implant
* Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
* Presence of auto immune diseases, or conditions requiring immunosuppression.

Primary outcomes:
measure: Patient Experience Measure
timeFrame: 9 months post implant
Secondary outcomes:
measure: Modified Box and Blocks
timeFrame: 9 months post implant
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Dustin J. Tyler, PhD
role: PRINCIPAL_INVESTIGATOR
References: