Healthy Participants
Conditions
Brief summary
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
DEVICESpinal 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 testing on each device.
Sponsors
Gail Forrest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg EMG activity during spinal stimulation | up to 6 weeks | Participants will have electrodes connected to the STEPPS stimulator, placed over spinal site locations (T10/11 \& T11/12). These electrodes will send an electrical current to their spine while laying on their back. Additional electrodes will be placed over right leg muscles to measure leg EMG muscle activation during the spinal stimulation. The same procedures will be used for the ARC-ex stimulator. Four trials of each stimulation device with EMG recording will be given over the course of 4 hours each visit for 3 visits. Mean/standard deviation curves and correlation coefficients for right leg muscle activation will be calculated to compare curves for NRT (pre-existing data) and each stimulator. |
Countries
United States
Contacts
CONTACTResearch Manager
Outcome results
None listed