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

Sponsor

SCI Research Advancement (Other)

Overall Status

Unknown status

CT.gov ID

NCT04097015

Collaborator

DuBois Vision Clinic (Other)

Enrollment

Location

Arm

1.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The intervention model is a single group assignment.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 :

Sep 20, 2019

Anticipated Primary Completion Date :

Oct 31, 2019

Anticipated Study Completion Date :

Nov 18, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain reduction measured by Pain Questionnaire [6 weeks]
Reduce neuropathic pain

Secondary Outcome Measures

Functional movement as measured by the ASIA Motor Score [6 weeks]
Movement below the SCI

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Home site	Buellton	California	United States	93427

Sponsors and Collaborators

SCI Research Advancement
DuBois Vision Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SCI Research Advancement

ClinicalTrials.gov Identifier:

NCT04097015

Other Study ID Numbers:

SCIRA001

First Posted:

Sep 20, 2019

Last Update Posted:

Oct 8, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

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:

Spinal Cord Injuries

Neuralgia

Wounds and Injuries

Study Results

No Results Posted as of Oct 8, 2019