New device aims to zap diabetic nerve pain
NCT ID NCT07250828
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a spinal cord stimulator (BurstDR) to relieve chronic pain from diabetic neuropathy. Twenty adults with long-lasting leg pain will try a temporary device for one week. If their pain drops by at least half, they can get a permanent implant. The study tracks pain levels, quality of life, and safety over six months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 19 years or older. * Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy. * Persistent neuropathic pain in the lower extremities for ≥6 months. * Average baseline pain score of ≥6 on the Visual Analog Scale (VAS). * DN4 score ≥4, indicating neuropathic pain characteristics. * Inadequate pain relief with conventional medical therapy, including at least two classes of analgesic or neuropathic pain medications (e.g., gabapentinoids, SNRIs, TCAs, opioids). * Candidate for spinal cord stimulation based on clinical evaluation by the treating physician. * Able and willing to comply with all trial procedures and follow-up visits. * Able to provide written informed consent in English or in an IRB-approved translated language. Exclusion Criteria: * Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful. * Contraindications to SCS placement, including: * Active systemic infection or local infection at planned needle entry site * Bleeding disorders or inability to temporarily discontinue anticoagulation if required * Known allergy to device materials or components * Severe uncontrolled medical conditions that increase surgical risk, including: * Unstable cardiovascular disease * Severe renal or hepatic dysfunction * Uncontrolled diabetes (e.g., HbA1c \> 10%) * Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance. * Current substance use disorder, including active opioid misuse or illicit drug use, based on clinician assessment. * Pregnancy or planning to become pregnant during the study period. * Life expectancy less than 12 months. * Participation in another interventional clinical trial that may confound results or interfere with study procedures. * Any condition that, in the investigator's opinion, makes the participant unsuitable for SCS therapy or the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic pain are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Grand Island Pain Relief Center
Grand Island, Nebraska, 68803, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One 2-Hour class may help new mothers manage Post-Cesarean pain
- Zapping deep brain regions to quiet chronic back pain
- Herbal injections at acupuncture points tested against physical therapy for Long-Lasting sciatica
- Can difficulty naming emotions shape how much tailbone pain you feel?
- Can talk therapy rewire the brain to ease burn Survivors' pain?
- Can a video game teach cancer patients to tame their pain?