Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Lo… (NCT04909138) | Clinical Trial Compass
RecruitingNot Applicable
Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy
United States30 participantsStarted 2022-10-15
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.