Spinal Cord Stimulation for Chronic Pain
(MED Trial)
Trial Summary
Will I have to stop taking my current medications?
No, you won't have to stop taking your current medications. The trial requires that you stay on your stable chronic pain medications without changing the dose until the study is completed or you withdraw from it.
What data supports the effectiveness of the treatment MED HF10™ Spinal Cord Stimulation for chronic pain?
Is spinal cord stimulation at 10 kHz safe for humans?
How is the MED HF10™ Spinal Cord Stimulation treatment different from other treatments for chronic pain?
The MED HF10™ Spinal Cord Stimulation treatment is unique because it uses high-frequency (10 kHz) stimulation to relieve pain without causing paresthesia (a tingling sensation), which is common in other spinal cord stimulation therapies. This treatment is also effective for patients who did not benefit from conventional spinal cord stimulation.12345
What is the purpose of this trial?
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
Research Team
Mayank Gupta, MD
Principal Investigator
Neuroscience Research Center
Eligibility Criteria
This trial is for individuals with chronic, intractable back and/or leg pain (sciatica) who already have Nevro Spinal Cord Stimulation (SCS) devices implanted. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulse dosing adjustments to find the lowest preferred pulse dose setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MED HF10™ Spinal Cord Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nevro Corp
Lead Sponsor