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Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
NCT05301335 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction
Conditions Studied
Interventions
- DEVICE SCONE
Study Locations (12)
California
- Rancho Research Institute — Downey
- UC San Diego Health Systems — San Diego
Colorado
- Craig Hospital — Denver
District of Columbia
- Medstar National Rehab — Washington D.C.
Florida
- University of Miami, Desai Sehti Urology Institute — Miami
Georgia
- Shepherd Centre — Atlanta
Massachusetts
- Spaulding Rehabilitation Hospital Cambridge — Cambridge
Minnesota
- Mayo Clinic, St. Mary's Campus — Rochester
New York
- Columbia University Irving Medical Centre — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2024-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05301335
The ClinicalTrials.gov registry entry for NCT05301335 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SpineX, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention — of which SCONE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05301335 reports 12 study locations spanning 11 distinct geographic areas — top geographies include California, Colorado, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05301335 about?
NCT05301335 is a clinical study titled "Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study". The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction
What is the current status of trial NCT05301335?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2022-05-25. Estimated completion is 2024-05-01.
What conditions does trial NCT05301335 study?
This clinical trial studies the following conditions: Stroke, Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Injuries (Complete and Incomplete). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05301335?
The interventions under investigation include: SCONE (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05301335?
This trial is sponsored by SpineX, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05301335 being conducted?
This trial has 12 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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