An interventional study of Alpha-Stim M in Spinal Cord Injuries and Pain, Neuropathic, sponsored by SCI Research Advancement. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by SCI Research Advancement · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 1 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with SCI Research Advancement as lead sponsor.
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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.
Device: Alpha-Stim M
Alpha-Stim M with and Ocular Interface and a Spinal Interface
Pain reduction measured by Pain Questionnaire
Reduce neuropathic pain
Time frame: 6 weeks
Functional movement as measured by the ASIA Motor Score
Movement below the SCI
Time frame: 6 weeks
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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