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NCT02641223 · ClinicalTrials.gov registry record
Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation
A clinical trial, sponsored by University of California, Davis.
- Completed
- Registry status
- 9
- Enrollment target
NCT02641223 is a clinical trial that has completed, run by University of California, Davis. The registered enrollment target is 9 participants.
The verdict
NCT02641223 has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study Summary
For this study the investigators will conduct five-day trial periods for spinal cord stimulator (SCS) effectiveness-once a patient is deemed to be a possible SCS candidate, the trial leads are implanted and they are asked to return to clinic in five days to evaluate the effectiveness of the trial. The primary outcome for this study will be a comparison of daily energy expenditure (EE), in units of kcal/day, prior to and after the trial implantation of the SCS leads and external pulse generator. Patients will wear the accelerometer device twenty-four hours a day for five days prior to the trial lead implantation to obtain baseline values, have the trial leads implanted in the procedure clinic, then continue to wear the accelerometer for another five days. Baseline and post-SCS energy expenditure values will be compared. The secondary outcomes for this study will be steps taken, hours of sleep, and Oswestry Disability Index (ODI, as described in appendix 1) during the pre and post trial implantation periods. SCS itself is not a research procedure in this study, rather it is part of routine medical care for patients who would benefit from the procedure.
Interventions
- DEVICE spinal cord stimulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02641223
The ClinicalTrials.gov registry entry for NCT02641223 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which spinal cord stimulator is the first listed.
NCT02641223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02641223 about?
NCT02641223 is a clinical study titled "Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation". For this study the investigators will conduct five-day trial periods for spinal cord stimulator (SCS) effectiveness-once a patient is deemed to be a possible SCS candidate, the trial leads are implanted and they are asked to return to clinic in five days to evaluate the effectiveness of the trial. T...
What is the current status of trial NCT02641223?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2015-11. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02641223?
The interventions under investigation include: spinal cord stimulator (DEVICE).
Who is sponsoring clinical trial NCT02641223?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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