A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01923662|
Recruitment Status : Recruiting
First Posted : August 15, 2013
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Paralysis Tetraplegia Paraplegia||Device: IST-16 (16-Channel implanted stimulator-telemeter||Not Applicable|
Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions.
In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploiting Selective Recruitment to Prolong Standing After SCI|
|Actual Study Start Date :||April 11, 2013|
|Estimated Primary Completion Date :||April 10, 2019|
|Estimated Study Completion Date :||April 10, 2019|
Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.
Device: IST-16 (16-Channel implanted stimulator-telemeter
Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.
- Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject. [ Time Frame: 12 months post-rehabilitation ]The investigators will assess standing performance in terms of elapsed standing time with various stimulation paradigms. The investigators will also collect data related to subjective impression of stability.
- Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject. [ Time Frame: 12 months post-rehabilitation ]Determine the amount of weight on both arms and legs during standing. During standing performance the investigators will also assess standing stability in terms of variations in knee joint angle and location of body center of mass while standing with various stimulation paradigms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923662
|Contact: Lisa M Lombardo, MPT||(216) 791-3800 ext 4909||Lisa.Lombardo2@va.gov|
|Contact: Tara A Byrd, BS||(216) 791-3800 ext email@example.com|
|United States, Ohio|
|Louis Stokes VA Medical Center, Cleveland, OH||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 Lisa.Lombardo2@va.gov|
|Contact: Tara A Byrd, BS (216) 791-3800 ext 4864 firstname.lastname@example.org|
|Principal Investigator: Ronald Triolo, PhD|
|Principal Investigator:||Ronald Triolo, PhD||Louis Stokes VA Medical Center, Cleveland, OH|