Trial Outcomes & Findings for Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury (NCT NCT00583804)

Last Updated: 2025-10-03

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

10 participants

Primary outcome timeframe

One Year

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Implanted Individuals Individuals implanted with stimulator/sensor device. These individuals were implanted with the IST-12 device. The IST-12 is an implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. The device was implanted in the chest, hand and arm to provide functional grasp and reach. All participants received the implanted device. During the primary outcome testing, the device was tested with the device "on" and active and compared with the results when the device was turned off. No blinding of either the subject or evaluator was possible because of the obvious response when the stimulator is on (i.e. the hand opens and closes when the stimulator is on; the hand is paralyzed when the stimulator is off).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implanted Individuals n=10 Participants Individuals implanted with stimulator/sensor device. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Grasp-Release Test - Baseline	2 Objects n=5 Participants

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Stimulation ON n=10 Participants Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.	Stimulation OFF n=10 Participants Function with stimulation turned off. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
Grasp-Release Test	5.5 Number of Objects Interval 5.0 to 6.0	2 Number of Objects Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Stimulation ON n=10 Participants Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.	Stimulation OFF Function with stimulation turned off. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
Activities of Daily Living Test	6 Number of Tasks Improved Interval 2.0 to 11.0	—

SECONDARY outcome

Timeframe: From date of implant until study completion or date of death from any cause.

Self-reported adverse events.

Outcome measures

Outcome data not reported

Adverse Events

Implanted Individuals

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Implanted Individuals n=10 participants at risk Individuals implanted with stimulator/sensor device. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. Note that all subjects received the implanted device and used the device in the laboratory and at home throughout the course of the study. Therefore there is only a single Arm for adverse events - all subjects received the intervention and stimulation.
Infections and infestations Device infection	20.0% 2/10 • Number of events 2

Additional Information

Principal Investigator

MetroHealth Medical Center

Phone: 2169573683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place