Status:
COMPLETED
Sub-threshold DRG Stimulation vs Sham in Established Responders
Lead Sponsor:
Umeå University
Conditions:
Neuropathic Pain
Complex Regional Pain Syndromes (CRPS)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 impl...
Detailed Description
Neuropathic pain is a chronic condition that affects 6-10% of adults and is often resistant to conventional drug therapy. The dorsal root ganglion (DRG) has emerged as an important therapeutic target,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07170722
Start Date
September 1 2025
End Date
November 30 2025
Last Update
December 5 2025
Active Locations (1)
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1
Neurokirurgiska kliniken. Neuromodulationsenheten
Umeå, Västerbotten County, Sweden, 90185