Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
Rush University Medical Center
Summary
This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area. Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period. Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.
Description
Dorsal Root Ganglion (DRG) is a novel target of neuromodulation that's use has grown as a proven effective treatment in chronic painful conditions. Studies examining tonic, paresthesia-based dorsal column stimulation have demonstrated plateauing or diminishing effects after extended time periods. Although not yet studied in DRG stimulation due to its relative infancy, the possibility of decreased pain relief over time very much exists. In order to mitigate the potential for waning pain relief over time, other paradigms of stimulation within the framework of DRG therapy must be evaluated. Inte…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age between 18 and 99 * 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain * Endorse at least 50% pain relief in the targeted area over the last year * Must have been seen for routine follow-up within last 4 months * Must have been reprogrammed in standard fashion at least once prior to randomization * Willing and able to complete protocol requirements, including: * Complete health questionnaires and pain scales as specified in the protocol…
Interventions
- DeviceDRG stimulation 20 Hz 30/90
Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF
- DeviceDRG stimulation 5 Hz 30/90
Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF
Location
- Rush University Medical CenterChicago, Illinois