Spinal Cord InjuryNCT00583804
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
A study testing IST-12 in people with Spinal Cord Injury and Tetraplegia, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia
- What is being tested?
- IST-12
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 1989to Sep 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- C5-C8 spinal cord injury
- Minimum of one-year post injury with no additional function prior to implantation surgery
- Male or female
- 18-60 years of age
- intact vision
- pharmacologically controlled spasticity, when applicable
Show all 13Show fewer
- Functional in wheelchair with adequate trunk support to allow bimanual manipulation
- Positive attitude and motivation with supportive home environment
- Willingness to return to laboratory for periodic evaluation and testing
- Free of contractures known to diminish performance of the system (e.g., supination contracture of the wrist).
- Integrity of the lower motor neuron (peripheral nerve) to the muscles to be activated
- Adequate range of motion of joints of the shoulder, wrist, and hand (upper extremity).
- If an acute infection is present, the subject will not be considered for surgery until it clears.
Who cannot join
- Prior history of a major chronic systemic infection or other illness that would increase the risk of surgery.
- Contraindications include immunologic diseases, cardiac arrhythmias, undiagnosed or high-risk breast masses, dermatologic conditions, and any major system failure.
- Acute infection currently present that has not cleared.
- Hypersensitivity that inhibits their ability to sustain pressure over their digits.
- Blind
- Uncontrolled disorders, i.e., seizures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.
Read the detailed description
The design of this study is to determine the efficacy of improving upper extremity function in tetraplegic subjects after receiving an implantable device for neuromuscular control. Evaluations will be made so as to document changes in performance of manipulative tasks when using the stimulation system.
Subjects who consent to participate in this project will have an implantable stimulator surgically placed in the upper extremity for control of the upper extremity. A series of tests will be performed before implantation, and repeated at intervals after implantation to assess changes in each subject's performance.
This study is a non-randomized feasibility study with concurrent (neuroprosthesis on and off) and longitudinal (pre- and post-implantation/training) self-controls.
Subjects participating in the study can expect to be actively involved in the study for two years after implantation and followed for life thereafter. The screening procedures take up to two days, depending on the specific evaluations necessary to determine candidacy. Pre-surgical exercise is conducted for at least two weeks. The implantation surgery itself lasts one day, with three to seven days of post-surgical hospitalization. Following an eight-week exercise program and a twelve-week training program, subjects are discharged from the active rehabilitation phase. They are followed quarterly for one year, and then annually thereafter.
The device is referred to as the Implanted Stimulator-Telemeter (IST) -12. The device uses functional electrical stimulation (FES) to activate paralyzed muscles.
- Conditions
- Spinal Cord Injury, Tetraplegia
- Being tested
- IST-12
- Keywords
- Spinal Cord Injury, Tetraplegia, Functional Electrical Stimulation, Neuroprosthesis
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IST-12Device
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation ON | Experimental | Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active. Receives: Device: IST-12 |
| Stimulation OFF | Active comparator | Function with stimulation turned off. Receives: Device: IST-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasp-Release Test
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.
Measured: One Year
Activities of Daily Living Test
The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent".
Measured: Three months
Secondary outcomes (1)
Adverse Events
Self-reported adverse events.
Measured: From date of implant until study completion or date of death from any cause.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study start1 Apr 1989
- Primary completion1 Jan 2015
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, VA Office of Research and Development, FDA Office of Orphan Products Development
- Responsible party
- Principal investigator, Kevin Kilgore, MetroHealth Medical Center
- Investigators
- Kevin L Kilgore, Ph.D., Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583804
- Sponsor's protocol ID
- IRB89-00027
- Other IDs
- VA Merit Review A3707R
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2007
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Peckham PH, Kilgore KL, Keith MW, Bryden AM, Bhadra N, Montague FW. An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. J Hand Surg Am. 2002 Mar;27(2):265-76. doi: 10.1053/jhsu.2002.30919.
PubMed 11901386Kilgore KL, Bryden A, Keith MW, Hoyen HA, Hart RL, Nemunaitis GA, Peckham PH. Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):252-264. doi: 10.1310/sci2403-252.
PubMed 29997428Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910.
PubMed 11588741Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.
PubMed 18406958
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00583804
- Acronym / sponsor ID
- IRB89-00027
- Conditions
- Spinal Cord Injury, Tetraplegia
- Keywords
- Spinal Cord Injury, Tetraplegia, Functional Electrical Stimulation, Neuroprosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, VA Office of Research and Development, FDA Office of Orphan Products Development
- Study start
- 1 Apr 1989 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.
Detailed description
The design of this study is to determine the efficacy of improving upper extremity function in tetraplegic subjects after receiving an implantable device for neuromuscular control. Evaluations will be made so as to document changes in performance of manipulative tasks when using the stimulation system.
Subjects who consent to participate in this project will have an implantable stimulator surgically placed in the upper extremity for control of the upper extremity. A series of tests will be performed before implantation, and repeated at intervals after implantation to assess changes in each subject's performance.
This study is a non-randomized feasibility study with concurrent (neuroprosthesis on and off) and longitudinal (pre- and post-implantation/training) self-controls.
Subjects participating in the study can expect to be actively involved in the study for two years after implantation and followed for life thereafter. The screening procedures take up to two days, depending on the specific evaluations necessary to determine candidacy. Pre-surgical exercise is conducted for at least two weeks. The implantation surgery itself lasts one day, with three to seven days of post-surgical hospitalization. Following an eight-week exercise program and a twelve-week training program, subjects are discharged from the active rehabilitation phase. They are followed quarterly for one year, and then annually thereafter.
The device is referred to as the Implanted Stimulator-Telemeter (IST) -12. The device uses functional electrical stimulation (FES) to activate paralyzed muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation ON | Experimental | Device: IST-12Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active. |
| Stimulation OFF | Active comparator | Device: IST-12Function with stimulation turned off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- C5-C8 spinal cord injury
- Minimum of one-year post injury with no additional function prior to implantation surgery
- Male or female
- 18-60 years of age
- intact vision
Key exclusion criteria (6 listed)
- Prior history of a major chronic systemic infection or other illness that would increase the risk of surgery.
- Contraindications include immunologic diseases, cardiac arrhythmias, undiagnosed or high-risk breast masses, dermatologic conditions, and any major system failure.
- Acute infection currently present that has not cleared.
- Hypersensitivity that inhibits their ability to sustain pressure over their digits.
- Blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IST-12Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. | Device | Stimulation OFF, Stimulation ON |
Primary outcome
Grasp-Release Test
Time frame: One Year
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.
Activities of Daily Living Test
Time frame: Three months
The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent".
1 secondary outcome
Adverse Events
Time frame: From date of implant until study completion or date of death from any cause.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11901386Peckham PH, Kilgore KL, Keith MW, Bryden AM, Bhadra N, Montague FW. An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. J Hand Surg Am. 2002 Mar;27(2):265-76. doi: 10.1053/jhsu.2002.30919.
- Background: PubMed 29997428Kilgore KL, Bryden A, Keith MW, Hoyen HA, Hart RL, Nemunaitis GA, Peckham PH. Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):252-264. doi: 10.1310/sci2403-252.
- Results publication: PubMed 11588741Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910.
- Results publication: PubMed 18406958Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007.
- Cleveland FES CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L Kilgore, Ph.D. principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IST-12 in people with Spinal Cord Injury and Tetraplegia, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grasp-Release Test (time frame: One Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583804, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.