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NCT04909138 · ClinicalTrials.gov registry record · NA
Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
A NA study of Peripheral Neuropathy and Radiculopathy, sponsored by Rush University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04909138: Recruiting NA study of Peripheral Neuropathy and Radiculopathy, sponsored by Rush University Medical Center.
NCT04909138 is a NA study of Peripheral Neuropathy and Radiculopathy that is actively recruiting participants, run by Rush University Medical Center. The registered enrollment target is 30 participants, below the 79-participant average among 27 other Peripheral Neuropathy trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04909138, a NA study of Peripheral Neuropathy and Radiculopathy, is actively recruiting participants, sponsored by Rush University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE DRG stimulation 20 Hz 30/90
- DEVICE DRG stimulation 5 Hz 30/90
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-10-15 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT04909138 shows while recruiting
NCT04909138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 79-participant average among 27 other Peripheral Neuropathy trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Peripheral Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which DRG stimulation 20 Hz 30/90 is the first listed.
NCT04909138 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04909138 about?
NCT04909138 is a clinical study titled "Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy". 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...
What is the current status of trial NCT04909138?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-10-15. Estimated completion is 2027-06.
What conditions does trial NCT04909138 study?
This clinical trial studies the following conditions: Peripheral Neuropathy, Radiculopathy, CRPS (Complex Regional Pain Syndromes).
What interventions are being tested in trial NCT04909138?
The interventions under investigation include: DRG stimulation 20 Hz 30/90 (DEVICE), DRG stimulation 5 Hz 30/90 (DEVICE).
Who is sponsoring clinical trial NCT04909138?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04909138 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04909138's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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