NCT04097015

Using NI-ES to Treat Spinal Cord Injury (SCI)

Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: SCI Research Advancement · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

NI-ES therapy is a treatment that is being studied to potentially treat pain associated with SCI and may help movement below the injury site.

Detailed description

The overall goal of this study is to assess the use of externally applied micro-current electrical stimulation in a subject with SCI to reduce pain and patient perceived improvement of quality of life first, and second, movement below the SCI injury. The Hypothesis is that NI-ES is beneficial in reducing pain following SCI injury, patient perceived quality of life measures, and functional outcomes. We plan to achieve this goal by conducting a Pain Questionnaire and assessment of movement below the injury site prior to external micro-current electrical stimulation with the Spinal Stim (Alpha-Stim M with the Ocular Interface and the Spinal Interface) and again six weeks following the first treatment. These results will be used to characterize the extent and duration of any improvement in pain and movement as a result of treatment with the Spinal Stim.

Conditions

• Spinal Cord Injuries
• Pain, Neuropathic

Interventions

Type	Name	Description
DEVICE	Alpha-Stim M	Alpha-Stim M with and Ocular Interface and a Spinal Interface

Timeline

• Start date: 2019-09-20
• Primary completion: 2019-10-31
• Completion: 2019-11-18
• First posted: 2019-09-20
• Last updated: 2019-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study