Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00583804
Brief 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.
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:
NCT00583804
Study Brief:
Protocol Section:
NCT00583804