Back to results

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

Primary Purpose

Spinal Cord Injuries, Pain, Neuropathic

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alpha-Stim M

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Electrical Stimulation, Transcutaneous, Spinal Cord Injury, Neutrophic Pain, Functional Movements

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Home site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain reduction measured by Pain Questionnaire

Reduce neuropathic pain

Secondary Outcome Measures

Functional movement as measured by the ASIA Motor Score

Movement below the SCI

Full Information

NCT ID

NCT04097015

First Posted

September 15, 2019

Last Updated

October 4, 2019

Sponsor

SCI Research Advancement

Collaborators

DuBois Vision Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04097015

Brief Title

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

Official Title

Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

October 31, 2019 (Anticipated)

Study Completion Date

November 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCI Research Advancement

Collaborators

DuBois Vision Clinic

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Pain, Neuropathic

Keywords

Electrical Stimulation, Transcutaneous, Spinal Cord Injury, Neutrophic Pain, Functional Movements

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The intervention model is a single group assignment.

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Alpha-Stim M

Intervention Description

Alpha-Stim M with and Ocular Interface and a Spinal Interface

Primary Outcome Measure Information:

Title

Pain reduction measured by Pain Questionnaire

Description

Reduce neuropathic pain

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Functional movement as measured by the ASIA Motor Score

Description

Movement below the SCI

Time Frame

6 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Home site

City

Buellton

State/Province

California

ZIP/Postal Code

93427

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs