NCT06541015

Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients

TENS (Transcutaneous Electrical Nerve Stimulation): Effect of Transcutaneous Spinal Direct Current Stimulation on Lower Limb Reflex, Volitional, and Functional Movement Post-stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.

Detailed description

The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. During the first session, the subjects will be screened and informed about the research study, so they can consent to their participation. They will also be oriented to the lab, the equipment, as well as the research team. Following the orientation, the remaining time will consist of approximately 3 hours of data collection. The remaining will last approximately 3 hours and consist of the completion of data collection. Additional sessions after 15 sessions will be optional and will be reserved for completing data collection if the subject is unable to complete a trial session or to analyze for test retest variability within the subject population. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time. The data will be analyzed and ready for grant preparation (if successful) in approximately four months after the start of the study.

Conditions

• Hemiplegia and/or Hemiparesis Following Stroke
• Anterior Circulation Stroke of Uncertain Pathology

Interventions

Type	Name	Description
DEVICE	InTENSity 10 TENS Stimulator	InTENSity 10 TENS stimulator is a portable electrotherapy device featuring Transcutaneous Electrical Nerve Stimulation (TENS) therapeutic device. The stimulator sends a gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons.

Timeline

• Start date: 2019-06-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-07
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study