Spinal Cord InjuryPhase 1INI-SCINCT07384052
Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
A Phase 1 study testing Regular Insulin and 0.9 % Normal Saline in people with Spinal Cord Injury, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Regular Insulin and 0.9 % Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 and <85 years of age
- Subject has sustained a traumatic or non-traumatic spinal cord injury with American Spinal Injury Association (ASIA) rating A, B, C or D, complete or incomplete
- Subject sustained spinal cord injury at least 4 months before baseline visit
- Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal / surgically sterile
- The subject must be proficient in English in order to comply with instructions and measures for the study
- Subject is able to prepare and administer the study drug as outlined in the protocol or has a carer who is available to do so for the duration of the study
- Subject can provide written informed consent
- Subject has been on a stable regimen of medications for at least 30 days from baseline visit
Who cannot join
- Subject is dependent on a ventilator or has a patent tracheostomy site
- Subject has recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a sudden rise in systolic BP greater than 20 mmHg or diastolic BP greater than 10 mmHg without rise in heart rate and accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, or blurry vision
- Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies
- Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
- Subject has participated in a clinical trial investigation within 3 months of this study
- Subject has a history of allergy, hypersensitivity, or other significant adverse reaction to insulin
Show all 9Show fewer
- Subject is taking insulin for Type I or Type II diabetes
- Subject is pregnant or breast feeding
- Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bethany K Crouse, PhD contact
United States1 site, 1 recruiting
- Recruiting
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
Meghan E O'Brien, MPH, 651-495-6363, Meghan.E.Obrien@HealthPartners.com
Bethany K Crouse, PhD, Bethany.K.Crouse@HealthPartners.com
About this study
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future.
This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.
- Conditions
- Spinal Cord Injury
- Being tested
- Regular Insulin, 0.9 % Normal Saline
- Keywords
- Insulin, Intranasal, Safety, Feasibility, Spinal Cord Injury, SCI, INI
- Medical subject headings
- Spinal Cord Injuries, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular InsulinDrug
Also called Novolin-R
Administered Intranasally at 76 IU
0.9 % Normal SalineOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Insulin | Experimental | Regular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days Receives: Drug: Regular Insulin |
| Placebo | Placebo comparator | 0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days Receives: Other: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by number of serious adverse events (SAE) and adverse events (AE)
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. AEs counts will include total count and will be stratified by severity.
Measured: 3 weeks
Secondary outcomes (5)
Treatment adherence as assessed by participant Daily Drug Diaries
Number of doses successfully administered as reported by participants in their daily drug diaries
Measured: 3 weeks
Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist
Average score on virtual training compliance checklist, both arms combined
Measured: Baseline Visit
Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey
Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined
Measured: Baseline
Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist
Participants will be trained to perform a blood spot collection procedure independently. Feasibility will be measured by the average score on blood spot procedure compliance checklist, both arms combined
Measured: Screening Visit
Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey
Acceptability of performing blood spot procedure independently will be measured by the average score on a blood spot procedure post-training acceptability survey, both arms combined
Measured: Screening Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start20 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 into one of 2 groups: 76 IU insulin, or saline (placebo) control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Leah R Hanson, PhD, Principal investigator, HealthPartners InstituteKimberly Byrnes, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384052
- Sponsor's protocol ID
- A22-210-01
- Other IDs
- CDMRP-SC220220
- Acronym
- INI-SCI
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07384052
- Acronym / sponsor ID
- INI-SCI / A22-210-01
- Conditions
- Spinal Cord Injury
- Keywords
- Insulin, Intranasal, Safety, Feasibility, Spinal Cord Injury, SCI, INI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Congressionally Directed Medical Research Programs
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future.
This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into one of 2 groups: 76 IU insulin, or saline (placebo) control
| Arm | Type | Receives |
|---|---|---|
| Intranasal Insulin | Experimental | Drug: Regular InsulinRegular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days |
| Placebo | Placebo comparator | Other: 0.9 % Normal Saline0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥18 and <85 years of age
- Subject has sustained a traumatic or non-traumatic spinal cord injury with American Spinal Injury Association (ASIA) rating A, B, C or D, complete or incomplete
- Subject sustained spinal cord injury at least 4 months before baseline visit
- Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal / surgically sterile
- The subject must be proficient in English in order to comply with instructions and measures for the study
Key exclusion criteria (9 listed)
- Subject is dependent on a ventilator or has a patent tracheostomy site
- Subject has recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a sudden rise in systolic BP greater than 20 mmHg or diastolic BP greater than 10 mmHg without rise in heart rate and accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, or blurry vision
- Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies
- Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
- Subject has participated in a clinical trial investigation within 3 months of this study
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 |
|---|---|---|
| Regular InsulinAlso: Novolin-RAdministered Intranasally at 76 IU | Drug | Intranasal Insulin |
| 0.9 % Normal SalinePlacebo Control | Other | Placebo |
Primary outcome
Safety measured by number of serious adverse events (SAE) and adverse events (AE)
Time frame: 3 weeks
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. AEs counts will include total count and will be stratified by severity.
5 secondary outcomes
Treatment adherence as assessed by participant Daily Drug Diaries
Time frame: 3 weeks
Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist
Time frame: Baseline Visit
Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey
Time frame: Baseline
Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist
Time frame: Screening Visit
Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey
Time frame: Screening Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Bethany K Crouse, PhD contact
Leah R Hanson, PhD principal investigator
HealthPartners Institute
Kimberly Byrnes, PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regular Insulin and 0.9 % Normal Saline in people with Spinal Cord Injury, run by HealthPartners Institute 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan E O'Brien, MPH (651-495-6363, Meghan.E.Obrien@HealthPartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by number of serious adverse events (SAE) and adverse events (AE) (time frame: 3 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 15 Sep 2026.