Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation

NAActive, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2026

Conditions
Chronic Pain
Interventions
DEVICE

High frequency spinal cord stimulation

We will use Senza® (Nevro Corp., Palo Alto, CA) trial and implant systems to deliver high frequency spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. High frequency waveform will be delivered with following parameters: frequency of 10,000 hertz, pulse width of 20 microseconds, and amplitude of 0-15 milliamperes.

DEVICE

Burst spinal cord stimulation

We will use BusrtDRTM (Abbott Saint Jude Medical, St. Paul, MN) trial and implant systems to deliver burst spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. The parameters of the stimulation are as below: each burst includes 5 pulses of electrical stimulation at intra-burst frequency of 500 hertz without time for discharge in between pulses. These bursts will be repeated at inter-burst frequency of 40-60 hertz. The amplitude will range between 0 and 15 milliamperes.

Trial Locations (1)

94063

Stanford Pain Management Center, Redwood City

All Listed Sponsors
lead

Stanford University

OTHER

NCT03681262 - Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation | Biotech Hunter | Biotech Hunter