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Coordinated Reset Spinal Cord Stimulation
Not Recruiting
Trial ID: NCT04997278
Purpose
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.
Official Title
Coordinated Reset Spinal Cord Stimulation
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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
Intervention(s):
device: Coordinated Reset spinal cord stimulation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Bet Anthony, MS
650-206-0536