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

RecruitingNAAges 18 Years - 90 YearsAllRush University Medical Center
NCT04909138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ev

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📋 Eligibility rules (as published)
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
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What it tests

  • DRG stimulation 20 Hz 30/90
  • DRG stimulation 5 Hz 30/90
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Where

1 site
Rush University Medical Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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