NCT04097015

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

September 15, 2019

Last Update Submit

October 4, 2019

Conditions

Spinal Cord InjuriesPain, Neuropathic

Keywords

Electrical Stimulation, TranscutaneousSpinal Cord InjuryNeutrophic PainFunctional Movements

Outcome Measures

Primary Outcomes (1)

  • Pain reduction measured by Pain Questionnaire

    Reduce neuropathic pain

    6 weeks

Secondary Outcomes (1)

  • Functional movement as measured by the ASIA Motor Score

    6 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Alpha-Stim MDEVICE

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

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • The presence of SCI
  • Pain associated with the SCI
  • Difficulty with body movement below the SCI

You may not qualify if:

  • Absence of SCI
  • Poor health
  • Deemed unsuitable for participation by the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home site

Buellton, California, 93427, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesNeuralgia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The intervention model is a single group assignment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 20, 2019

Study Start

September 20, 2019

Primary Completion

October 31, 2019

Study Completion

November 18, 2019

Last Updated

October 8, 2019

Record last verified: 2019-09

Locations

US(1)