NCT05301335

Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study

Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: SpineX Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Neurogenic Bladder
• Spinal Cord Injuries (Complete and Incomplete)
• Stroke
• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	SCONE	The Spinal COrd NEuromodulation(SCONE) device delivers a sufficient electrical signal non-invasively to activate the neural structures of the spinal cord without cutaneous discomfort. Rather than relying on stimulation of peripheral nerves, SCONE modulates the CNS directly via the spinal cord. Importantly, SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or implantation of stimulating electrodes

Timeline

• Start date: 2022-05-25
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-03-29
• Last updated: 2025-02-17

Locations

12 sites across 3 countries: United States, Canada, India

Regulatory

• FDA-regulated device study