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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04097015

Enrollment

Registered

2019-09-20

Start date

2019-09-20

Completion date

2019-11-18

Last updated

2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Neuropathic, Spinal Cord Injuries

Keywords

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

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.

Interventions

DEVICEAlpha-Stim M

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

The intervention model is a single group assignment.

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction measured by Pain Questionnaire	6 weeks	Reduce neuropathic pain

Secondary

Measure	Time frame	Description
Functional movement as measured by the ASIA Motor Score	6 weeks	Movement below the SCI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026