What this study is
The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.
What's being tested
- Spinal Cord Stimulation
Intervention · DEVICE
Intraoperatively, stimulation at 12 Hz will be performed as the leads are moved into the targeted position. Amplitude will be increased to 15 mA maximum total until a response is seen on any electrode and held for 10 seconds. Stimulation and recording will be performed using the Neuralynx stim/record system. Post-operatively, the electrodes will be tested for impedance by the clinical system and then they will be connected to the Neuralynx stim/record system. Electrode stimulation patterns will be applied with increasing amplitude until ECAPs responses are seen on recording electrodes. 42 Hz stimulation will be performed with an amplitude sweep of 0mA-10mA. At each amplitude, stimulation will be applied for 4 seconds followed by 2 seconds of rest. Pulse width will be varied from 30-450 microseconds to test effective amplitude. Bursting stimulation will be applied to detect differences in ECAPs as above.
Study details
- Sponsor
- University of Minnesota
- Conditions
- Chronic Pain
- Enrolling
- 15 people
- Starts
- 2021-08-18
- Est. completion
- 2026-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Medically stable as determined by the principal investigator
- Scheduled to undergo externalization of spinal cord stimulation
- English-speaking
You can't join if
- Scheduled for permanent implantation only without trial
- Have pacemakers or other neurostimulators
- Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Minnesota
Minneapolis, Minnesota, United States
Recruiting
Study team
Sponsor
University of Minnesota
Study ID NEUROSURG-2021-29717
Principal investigator
David Darrow, MD, MPH
University of Minnesota Medical School Department of Neurosurgery
Principal investigator
Alexander Herman, MD, PhD
University of Minnesota Medical School Department of Psychiatry
Principal investigator
Tay Netoff, PhD
University of Minnesota Department of Biomedical Engineering
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.