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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT04909138
Status
Recruiting
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Conditions

  • CRPS (Complex Regional Pain Syndromes)
  • Peripheral Neuropathy
  • Radiculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • DRG stimulation 20 Hz 30/90 — DEVICE
    Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF
  • DRG stimulation 5 Hz 30/90 — DEVICE
    Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF

Study Details

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 Dates

Start date
Oct 15, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF
    DRG stimulation therapy at 20 Hz (30 seconds ON, 90 seconds OFF)
  • Active Comparator: DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFF
    DRG stimulation therapy at 5 Hz (30 seconds ON, 90 seconds OFF)

Primary Outcome Measure

NRS pain scores [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Robert J McCarthy
[email protected]
3125630448

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By research site
Rush University Medical Center· Chicago, IL

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