RecruitingNot ApplicableNCT07217314

Testing a Non-Invasive Spinal Stimulation Device

Multi-Channel Spinal Transcutaneous Electrical Pulsed Stimulation System: STEPSS


Sponsor

Gail Forrest

Enrollment

10 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare an updated spinal stimulation device 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. This device was updated to improve upon limitations in the currently used device.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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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 2 hours to complete on each day. The 2 hours includes set-up/placement of the electrodes, 4 trials of stimulation with breaks, and removal of electrodes after testing.


Locations(1)

Kessler Foundation

West Orange, New Jersey, United States

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NCT07217314


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