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

Recruiting now · Not applicable

Conditions studied: CRPS (Complex Regional Pain Syndromes), Radiculopathy, Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT04909138

Run by

Rush University Medical Center

People needed

30

Starts

2022-10-15

Expected to finish

2027-06-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Rush University Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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