NCT04727216

Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Spine and Pain Institute of New York · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain

Detailed description

Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered. In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.

Conditions

• Pain, Intractable
• Pain, Chronic

Interventions

Type	Name	Description
DEVICE	Dorsal Root Ganglion Stimulation (DRG-S)	Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-08-01
• Completion: 2021-09-15
• First posted: 2021-01-27
• Last updated: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study