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

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ClinicalTrials.gov Identifier: NCT00583804
Recruitment Status : Active, not recruiting
First Posted : December 31, 2007
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Case Western Reserve University
VA Office of Research and Development
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Kevin Kilgore, MetroHealth Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Spinal Cord Injury
Tetraplegia
Intervention: Device: IST-12

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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).


Participant Flow:   Overall Study
    Implanted Individuals
STARTED   10 
COMPLETED   10 [1] 
NOT COMPLETED   0 
[1] Subjects were considered enrolled when they underwent implantation of the device. All completed.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Implanted Individuals

Individuals implanted with stimulator/sensor device.

IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.


Baseline Measures
   Implanted Individuals 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Median (Full Range)
 37 
 (26 to 56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  20.0% 
Male      8  80.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  10.0% 
Not Hispanic or Latino      9  90.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      10 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Grasp-Release Test - Baseline [1] 
[Units: Objects]
Median (Full Range)
 2 
 (0 to 4) 
[1] The Grasp-Release tests consists of six standard objects requiring different grasp patterns and forces to pick up and move. The subjects have a fixed period of time to attempt to acquire the object and move it from one location on the test board to a second location. The outcome is measured as the number of objects that they can successfully pick up and move. The minimum score is 0 and the maximum score is 6.


  Outcome Measures

1.  Primary:   Grasp-Release Test   [ Time Frame: One Year ]

2.  Primary:   Activities of Daily Living Test   [ Time Frame: Three months ]

3.  Secondary:   Adverse Events   [ Time Frame: From date of implant until study completion or date of death from any cause. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: MetroHealth Medical Center
phone: 2169573683
e-mail: ue.fes.clinicaltrials@gmail.com


Publications of Results:
Other Publications:

Responsible Party: Kevin Kilgore, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00583804     History of Changes
Other Study ID Numbers: IRB89-00027
VA Merit Review A3707R ( Other Grant/Funding Number: Dept. Veterans Affairs )
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: May 1, 2017
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018