Actively Recruiting
Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
Led by Rush University Medical Center · Updated on 2026-01-21
30
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 99 years
- Use of continuous DRG therapy delivered by a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and/or leg pain for at least 1 year
- At least 50% pain relief in the targeted area over the last year
- Seen for routine follow-up within the last 4 months
- Have been reprogrammed in standard fashion at least once before randomization
- Willing and able to complete health questionnaires, pain scales, and follow-up visits as specified
- Able to sign the study-specific informed consent form
You will not qualify if you...
- Significant lead migration as determined by the clinician
- Presence of another concurrent neuromodulation system
- Corticosteroid injection within 30 days prior to enrollment
- History of intermittent dosing failure within the last 6 months
- Changing or unstable pain medications within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
S
Sandeep Amin, MD
CONTACT
D
Daniel Torrez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here