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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04097015
• Other study ID #: SCIRA001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: September 2019
• Source: SCI Research Advancement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1
• Est. completion date: November 18, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain, Neuropathic
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Alpha-Stim M
Alpha-Stim M with and Ocular Interface and a Spinal Interface

Locations

Country	Name	City	State
United States	Home site	Buellton	California

Sponsors (2)

Lead Sponsor	Collaborator
SCI Research Advancement	DuBois Vision Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction measured by Pain Questionnaire	Reduce neuropathic pain	6 weeks
Secondary	Functional movement as measured by the ASIA Motor Score	Movement below the SCI	6 weeks