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NCT04157400 · ClinicalTrials.gov registry record · NA
Effect of Epidural Stimulation on Muscle Activation and Sensory Perception
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04157400 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 5 participants.
The verdict
NCT04157400, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Each year, an estimated 34,000 individuals undergo epidural spinal cord stimulation (SCS) surgery to address debilitating chronic low back and leg pain (CLBLP). Although the commercial application of SCS to treat CLBLP was approved by the FDA in 1989, only in the past decade have significant advancements in stimulator technology been introduced. For instance, traditional SCS devices achieved reduction in pain using a type of stimulation known as low-frequency tonic stimulation (LFTS, below 100 Hz), which was dependent on induction of paresthesias (i.e., a tingling sensation) over the areas of pain perception. However, investigators now know that LFTS compromises sensory information flowing back to the spinal cord, which can be important in other spinal cord functions such as proprioception and movement. On the other hand, recent innovations in stimulator technology now provide the capability to apply stimulation frequencies up to 10,000 Hz along with complex waveform patterns - known as high frequency burst stimulation or HFBS - that can mitigate pain perception without the induction of paresthesias and the negative consequences on proprioception and movement. We propose to study the effects of these recently introduced features in SCS technology on motor and sensory spinal thresholds, proprioception and movement in subjects with CLBLP. The spinal cord relies on input from the motor cortex and surrounding extremities to initiate specific muscle recruitment, and recent evidence suggests that preservation of temporally specific proprioceptive information via dorsal column primary afferent fibers is critical for natural motor behaviors such as ambulation. Since the spinal cord is exposed during the placement of the SCS device, information about a subject's motor and sensory spinal pathways can be easily obtained during the regular course of the procedure and compared to proprioceptive and motor responses once the subject is awake and moving with the device turned on.
Interventions
- DEVICE Intraoperative Parameter Testing
- DEVICE Proprioception Testing During Stimulation
- DEVICE Gait Analysis During Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2021-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04157400
The ClinicalTrials.gov registry entry for NCT04157400 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Intraoperative Parameter Testing is the first listed.
NCT04157400 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04157400 about?
NCT04157400 is a clinical study titled "Effect of Epidural Stimulation on Muscle Activation and Sensory Perception". Each year, an estimated 34,000 individuals undergo epidural spinal cord stimulation (SCS) surgery to address debilitating chronic low back and leg pain (CLBLP). Although the commercial application of SCS to treat CLBLP was approved by the FDA in 1989, only in the past decade have significant advance...
What is the current status of trial NCT04157400?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2019-11-26. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT04157400?
The interventions under investigation include: Intraoperative Parameter Testing (DEVICE), Proprioception Testing During Stimulation (DEVICE), Gait Analysis During Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04157400?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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