Spinal Cord InjuriesNCT04097015
Using NI-ES to Treat Spinal Cord Injury (SCI)
A study testing Alpha-Stim M in people with Spinal Cord Injuries and Pain, Neuropathic, run by SCI Research Advancement at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries, Pain, Neuropathic
- What is being tested?
- Alpha-Stim M
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female
- The presence of SCI
- Pain associated with the SCI
- Difficulty with body movement below the SCI
Who cannot join
- Absence of SCI
- Poor health
- Deemed unsuitable for participation by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Pain, Neuropathic
- Being tested
- Alpha-Stim M
- Keywords
- Electrical Stimulation, Transcutaneous, Spinal Cord Injury, Neutrophic Pain, Functional Movements
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Stim MDevice
Alpha-Stim M with and Ocular Interface and a Spinal Interface
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Alpha-Stim M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction measured by Pain Questionnaire
Reduce neuropathic pain
Measured: 6 weeks
Secondary outcomes (1)
Functional movement as measured by the ASIA Motor Score
Movement below the SCI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start20 Sep 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion18 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention model is a single group assignment.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCI Research Advancement
- Sponsor type
- University, hospital or other
- Collaborators
- DuBois Vision Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097015
- Sponsor's protocol ID
- SCIRA001
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04097015
- Acronym / sponsor ID
- SCIRA001
- Conditions
- Spinal Cord Injuries, Pain, Neuropathic
- Keywords
- Electrical Stimulation, Transcutaneous, Spinal Cord Injury, Neutrophic Pain, Functional Movements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SCI Research AdvancementUniversity, hospital or other
- Collaborators
- DuBois Vision Clinic
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 18 Nov 2019 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention model is a single group assignment.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Alpha-Stim MThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- The presence of SCI
- Pain associated with the SCI
- Difficulty with body movement below the SCI
Key exclusion criteria (3 listed)
- Absence of SCI
- Poor health
- Deemed unsuitable for participation by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Stim MAlpha-Stim M with and Ocular Interface and a Spinal Interface | Device | Treatment |
Primary outcome
Pain reduction measured by Pain Questionnaire
Time frame: 6 weeks
Reduce neuropathic pain
1 secondary outcome
Functional movement as measured by the ASIA Motor Score
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Stim M in people with Spinal Cord Injuries and Pain, Neuropathic, run by SCI Research Advancement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction measured by Pain Questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.