Coordinated Reset Spinal Cord Stimulation

Trial ID or NCT#

NCT04997278

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 22 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  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.
Exclusion Criteria:
  1. 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
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Investigator(s)

Peter Tass

Contact us to find out if this trial is right for you.

Contact

Bet Anthony, MS
650-206-0536

View on ClinicalTrials.gov