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

Not Applicable

• Conditions: Spinal Cord Injuries; Pain, Neuropathic
• Interventions: Device: Alpha-Stim M

• Registration Number: NCT04097015
• Lead Sponsor: SCI Research Advancement

Brief 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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-18
• Study Start: 2019-09-20
• Study First Posted: 2019-09-20
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Male or female
• The presence of SCI
• Pain associated with the SCI
• Difficulty with body movement below the SCI

Exclusion Criteria

• Absence of SCI
• Poor health
• Deemed unsuitable for participation by the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Alpha-Stim M	The treatment or intervention is the use of NI-ES using a signal generator, Alpha-Stim M, with an Ocular Interface connected to one channel and a Spinal Interface to the other channel. The treatment is done at home for 40 minutes at a time, twice a day. The upper lids of the closed eyes are treated for 10 minutes and the lower lids of the closed eyes are treated for 10 minutes, alternated throughout the treatment time. The Spinal Interface is placed above the SCI for 40 minutes. The entire procedure is repeated for another 40 minutes for a second time. The participant will treat himself at home.

Primary Outcome Measures

Name	Time	Method
Pain reduction measured by Pain Questionnaire	6 weeks	Reduce neuropathic pain

Secondary Outcome Measures

Name	Time	Method
Functional movement as measured by the ASIA Motor Score	6 weeks	Movement below the SCI

Trial Locations

Locations (1)

Home site; 🇺🇸 Buellton, California, United States