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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2019-11-18

Brief Summary

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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.

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Detailed Description

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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

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Spinal Cord Injuries Pain, Neuropathic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The intervention model is a single group assignment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL