NCT05968664

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Ashwin Viswanathan · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.

Detailed description

The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.

Conditions

• Chronic Pain
• Pain, Neuropathic
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulator	Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
DEVICE	Spinal Cord Stimulator	Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-08-01
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study