Intermittent Dorsal Root Ganglion Stimulation for Chronic Pain Relief
Official title: Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
Run by Rush University Medical Center · NCT04909138 · Data updated 2026-11-12
This study is testing if a new way of using nerve stimulation can help people with chronic pain feel better compared to the usual constant treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 15, 2022 |
| Main results expected | June 2026 |
| Study ends | June 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT04909138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 99 who have been using continuous DRG therapy for at least one year and have experienced a minimum of 50% pain relief.
✕Probably not a fit
Patients with significant lead migration or those who have had recent corticosteroid injections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of intermittent dosing of dorsal root ganglion (DRG) stimulation as an alternative to continuous low-frequency therapy for patients with chronic pain conditions. Participants will be randomized into two groups, receiving either 20 Hz or 5 Hz stimulation in an ON/OFF cycle. Each participant will undergo a crossover design, switching stimulation paradigms after 13 weeks. The study aims to assess pain relief and the potential for improved outcomes over time compared to traditional continuous stimulation methods.
Why it matters
Potential benefit: If successful, this approach could provide enhanced pain relief for patients suffering from chronic pain conditions.
How similar studies have gone: Previous studies on intermittent dosing in spinal cord stimulation have shown success, but this specific approach in DRG stimulation is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * Sign the study-specific informed consent form * Complete follow-ups at the designated time periods Exclusion Criteria: * Significant lead migration, as determined by clinician * Other concurrent neuromodulation system in place * Corticosteroid injection in previous 30 days prior to enrollment * Intermittent dosing and/or failure within last 6m * Changing or unstable pain medications within 30 days
Where it's running
-
Rush University Medical Center
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Sandeep Amin, MD
- Email: sandeep_amin@rush.edu
- Phone: 3129422966
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.