NCT04938245 · University of Minnesota
Improving Spinal Cord Stimulation With ECAPS
What this study is about
The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.
View original scientific description
The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.
Interventions
DEVICE
Spinal Cord Stimulation
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.
Primary outcome measures
Feasibility Assessed by Enrollment
Time frame: 2 weeks
Feasibility will be measured as a number of the number of enrolled participants who complete at least 80% of the planned assessments.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Medically stable as determined by the principal investigator
- Scheduled to undergo externalization of spinal cord stimulation
- English-speaking
Exclusion criteria
- Scheduled for permanent implantation only without trial
- Have pacemakers or other neurostimulators
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations