Testing Non-Invasive Spinal Stimulation Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Stimulation.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS
Overview
The purpose of this study is to compare updated spinal stimulation devices with the spinal stimulation device that is currently used. Spinal stimulation is often used in studies aimed at assisting individuals with a spinal cord injury. These devices were updated to improve upon limitations in the currently used device. The devices will be compared in a group of people without spinal cord injury or other nervous system conditions.
Interventions
- Device Spinal Stimulation
Participants will lay on their back and have small electrodes placed on the center of their backs and several leg muscles. The back electrodes, connected to a battery-operated unit, will send an electrical current to the spine. The leg electrodes will record muscle activity. This will take approximately 4 hours to complete on each day. The 4 hours includes set-up/placement of the electrodes for each device, 4 trials of stimulation for each device with breaks, and removal of electrodes after test
Primary outcome measures
- Leg EMG activity during spinal stimulation [Time frame: up to 6 weeks]
Eligibility criteria
Inclusion criteria
- At least 18 years of age
- Proficient in English
- Available for the testing session
- Able to give informed consent
- Able to tolerate spinal stimulation
Exclusion criteria
- Pregnant (female only).
- Untreated severe and persistent problems regulating blood pressure, heart rate, or other automatic functions.
- Any past or present injury or disease to the nervous system
- Heart or lung disease that may interfere with stimulation
- A skin condition in any area that may affect the ability to receive stimulation
- Taking any medication that may affect the ability to receive spinal stimulation
- Ongoing drug abuse
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Kessler Foundation — West Orange
Identifiers
NCT: NCT07217314 · R-1283-24