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Intermittent DRG Stimulation for Chronic Pain

This study is looking at a new way to deliver Dorsal Root Ganglion (DRG) stimulation for people who have had a DRG neurostimulator for at least a year and have experienced at least 50% pain relief. The study wants to see if giving the stimulation in short bursts (intermittent dosing) works as well as continuous stimulation. You would receive DRG stimulation for 30 seconds ON and 90 seconds OFF, either at 20 Hz or 5 Hz. The main goal is to see how your pain scores (NRS pain scores) change over up to 6 months. This study is for adults aged 18 to 90 who have Complex Regional Pain Syndromes (CRPS), Radiculopathy, or Peripheral Neuropathy.

Study design
This is an interventional study with 30 planned participants. You would be randomly assigned to one of two stimulation groups, and then switch to the other group after 13 weeks.
What's involved
You would receive different DRG stimulation settings over two 13-week periods. Routine follow-up within the last 4 months is required before joining.
Compensation
Not stated in the trial record.
Follow-up
Your pain scores will be measured for up to 6 months.

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NCT04909138

Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy

Recruiting
NAAges 18–90InterventionalTreatment
Rush University Medical Center
~30 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:DRG stimulation 20 Hz 30/90DRG stimulation 5 Hz 30/90

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
NRS pain scores
Measured over Up to 6 months

Conditions

CRPS (Complex Regional Pain Syndromes)
Radiculopathy
Peripheral Neuropathy

Explore related trials

Chronic PainComplex Regional Pain SyndromePeripheral NeuropathyRadiculopathy

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Robert McCarthy, PharmD · STUDY_DIRECTOR · Rush University Medical Center

Who to contact

Sandeep Amin, MD
[email protected]
3129422966
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • NRS pain scoresUp to 6 months

    Subject's Numeric Rating Scale (NRS) score for pain being treated by DRG simulation for up to 3 months of designated treatment on a 22 point scale from 0-10 in 0.5 increments with 0 being no pain to 10 being the worse imaginable pain.