Sub-threshold DRG Stimulation vs Sham in Established Responders (NCT07170722) | Clinical Trial Compass
CompletedNot Applicable
Sub-threshold DRG Stimulation vs Sham in Established Responders
Sweden20 participantsStarted 2025-09-01
Plain-language summary
The goal of this clinical trial is to learn if sub-threshold dorsal root ganglion (DRG) stimulation provides pain relief beyond placebo in adults with chronic neuropathic pain who already have an implanted DRG stimulator. The main questions it aims to answer are:
* Does sub-threshold DRG stimulation reduce daily pain intensity compared with sham stimulation?
* How does sub-threshold stimulation affect sleep, mood, and daily activity?
Researchers will compare active sub-threshold DRG stimulation to sham (device switched off) to see if stimulation has a genuine effect on pain and wellbeing.
Participants will:
* Be randomly assigned to receive either active sub-threshold DRG stimulation or sham stimulation for 5 days, followed by the opposite condition for another 5 days.
* Complete short electronic diaries twice daily about their pain, sleep, mood, and activity.
* Attend study visits for safety checks and assessments.
Who can participate
Age range
18 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:
* Adults, age 18 years or older
* Implanted with a dorsal root ganglion (DRG) stimulator for chronic neuropathic pain
* Have experienced at least 50% reduction in pain for 3 months or longer on standard DRG therapy
* Stable pain medication regimen for at least 4 weeks before enrollment
* Able and willing to complete electronic diaries and attend study visits
Exclusion Criteria:
* Active infection or wound complication at the stimulator implant site
* Significant psychiatric illness (for example, uncontrolled depression or psychosis)
* Planned surgery, device reprogramming, or medication changes during the study period
* Currently pregnant or breastfeeding
* Occurrence of any adverse event that meets predefined withdrawal criteria during the study (such as intolerable pain or device-related complications)
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.
What they're measuring
1
Average daily pain intensity (Numeric Rating Scale, 0-10)
Timeframe: Twice daily (morning and evening) from Day 0 through Day 11 (includes both 5-day treatment periods and the two 24-hour washout periods on Day 0 and Day 6).