Recruiting

Dorsal Root Ganglion Stimulation

Sponsor:

Rush University Medical Center

Code:

NCT04909138

Conditions

CRPS (Complex Regional Pain Syndromes)

Radiculopathy

Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DRG stimulation 20 Hz 30/90

DRG stimulation 5 Hz 30/90

Study Details

Brief summary:

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.

Conditions

CRPS (Complex Regional Pain Syndromes)

Radiculopathy

Peripheral Neuropathy

Study ID

NCT04909138

Start date

Oct 15, 2022

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

DRG stimulation 20 Hz 30/90

Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF

DRG stimulation 5 Hz 30/90

Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sandeep Amin, MD

3129422966sandeep_amin@rush.edu

Daniel Torrez, BS

312-942-2741Daniel_Torrez@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Robert J McCarthy

3125630448Robert_J_McCarthy@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Jan 21, 2026

Last verified

Dec, 2025

Keywords

  • Chronic Pain
  • Dorsal Root Ganglion Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-01-21.