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

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ClinicalTrials.gov Identifier: NCT04097015
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
DuBois Vision Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Pain, Neuropathic Device: Alpha-Stim M Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention model is a single group assignment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Alpha-Stim M
Alpha-Stim M with and Ocular Interface and a Spinal Interface




Primary Outcome Measures :
  1. Pain reduction measured by Pain Questionnaire [ Time Frame: 6 weeks ]
    Reduce neuropathic pain


Secondary Outcome Measures :
  1. Functional movement as measured by the ASIA Motor Score [ Time Frame: 6 weeks ]
    Movement below the SCI



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097015


Locations
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United States, California
Home site
Buellton, California, United States, 93427
Sponsors and Collaborators
SCI Research Advancement
DuBois Vision Clinic

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Responsible Party: SCI Research Advancement
ClinicalTrials.gov Identifier: NCT04097015     History of Changes
Other Study ID Numbers: SCIRA001
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by SCI Research Advancement:
Electrical Stimulation, Transcutaneous
Spinal Cord Injury
Neutrophic Pain
Functional Movements
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms