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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04097015
Other study ID # SCIRA001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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