Prospective Evaluation of the Optimal SCS Trial Length

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07709351
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulation (SCS) Trial — PROCEDURE
    This observational study will enroll approximately 42 subjects at The Ohio State University who are undergoing a spinal cord stimulation (SCS) trial as part of standard clinical care. No study-specific intervention will be assigned. Participants will be monitored to evaluate SCS trial outcomes, including pain scores, patient satisfaction, and decisions regarding permanent implantation. The sample size was selected to provide sufficient evaluable data while accounting for potential attrition and supporting descriptive and exploratory analyses.

Study Details

This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 28, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
42 participants (estimated)

Arms

  • Arm: SCS Trial Participants
    Participants undergoing a standard spinal cord stimulation (SCS) trial as part of routine clinical care will be observed. Daily pain scores, patient satisfaction, and decision-making regarding permanent SCS implantation will be collected during the trial period. No study-specific intervention will be administered; the study evaluates outcomes associated with the existing SCS trial process.

Primary Outcome Measure

Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes [ Time Frame: 15 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Nasir Hussain, MD
614-293-3559

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