Trial Search Results
Coordinated Reset Spinal Cord Stimulation
The goal of this study is to evaluate whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide equivalent or better pain relief with reduced energy requirements. The investigators will test this new stimulation paradigm in patients who are already undergoing spinal cord stimulation surgery. The investigators will also study whether there are changes in electroencephalography (brain waves) associated with this new stimulation paradigm.
The investigators hope to learn whether CR stimulation can provide equivalent or better pain relief with reduced energy requirements. They also hope to learn whether there are changes in brain function with effective CR stimulation compared to conventional stimulation.
This study will be testing a specific stimulation paradigm in people who have already consented to have spinal cord stimulation performed for treatment of their chronic pain.
Stanford is currently accepting patients for this trial.
- Device: Coordinated Reset spinal cord stimulation
Early Phase 1
1. Patients with chronic neuropathic lower extremity pain, without back pain, who have
consented to undergo or are undergoing spinal cord stimulation (SCS)
2. Age 22 to 70
3. Fluent in English and able to independently provide consent
4. Patients treated with conventional SCS for at least 3 months prior to commencement of
study, either newly implanted or already implanted.
5. Patients have pronounced pain, i.e. visual analog scale score (VAS) ≥6 and respond to
conventional SCS, i.e. VAS reduction of at least 50% with SCS.
1. Significant psychiatric problems, including unrelated clinically significant
depression as determined by the investigator.
2. Current drug or alcohol abuse as determined by the investigator.
3. Any history of recurrent or unprovoked seizures.
4. Any significant medical condition that is likely to interfere with study procedures or
likely to confound evaluation of study endpoints, including any terminal illness with
survival <12 months.
5. Females who are pregnant, breastfeeding, or are of childbearing potential and planning
to get pregnant during the course of the study or not using adequate contraception
6. On anticoagulation therapy
Ages Eligible for Study
22 Years - 70 Years
Genders Eligible for Study