Spinal Cord Injury, Tetraplegia
Conditions
Keywords
spinal cord injury, neuroprosthesis, functional electrical stimulation, quadriplegia
Brief summary
The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.
Detailed description
The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system known as the FIRSTHAND System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.
Interventions
DEVICEFIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* cervical level spinal cord injury; * complete paralysis of fingers and thumbs; * voluntary shoulder motion; * electrically excitable forearm and hand musculature
Exclusion criteria
* extreme contractures of the joints; * skeletal immaturity; * extensive denervation in the forearm and hand; * poor surgical risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grasp Release Test - Test of Functional Ability to Pick up and Move Objects | 6-9 weeks | Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) \[Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004\], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers \[Peckham, 2001\]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (\ 1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds. |
Countries
United States
Participant flow
Pre-assignment details
Note that the data from the first three (of 10) participants was published in the Journal of Hand Surgery (2008; 33(4):539-50).
Participants by arm
| Arm | Count |
|---|---|
| Neuroprosthesis System Receives implanted device for hand function.
FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Neuroprosthesis System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Grasp-Release Test | 2 Number of Completions |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Grasp Release Test - Test of Functional Ability to Pick up and Move Objects
Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) \[Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004\], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers \[Peckham, 2001\]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (\ 1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.
Time frame: 6-9 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Neuroprosthesis System | Grasp Release Test - Test of Functional Ability to Pick up and Move Objects | Rehab - NP OFF | 2 Number of Completions |
| Neuroprosthesis System | Grasp Release Test - Test of Functional Ability to Pick up and Move Objects | Rehab - NP ON | 5.5 Number of Completions |