Actively Recruiting
Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
Led by HealthPartners Institute · Updated on 2026-03-23
12
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
Sponsors
H
HealthPartners Institute
Lead Sponsor
U
Uniformed Services University of the Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to under 85 years
- Traumatic or non-traumatic spinal cord injury with ASIA rating A, B, C, or D, complete or incomplete
- Spinal cord injury occurred at least 4 months before baseline visit
- Female participants must have a negative pregnancy test at screening and treatment visits or be at least 2 years post-menopausal or surgically sterile
- Proficient in English to follow study instructions and assessments
- Able to prepare and administer the study drug or have a caregiver available to do so
- Able to provide written informed consent
- On a stable medication regimen for at least 30 days before baseline visit
You will not qualify if you...
- Dependent on a ventilator or has a patent tracheostomy
- History of recurrent autonomic dysreflexia within past 6 months
- Medical history of chronic sinusitis, prior nasal or oto-pharyngeal surgery, severe deviated septum, or related anomalies
- History of active or significant CNS, psychiatric, pulmonary, cardiovascular disorders, or other abnormalities posing safety risk
- Participated in a clinical trial within past 3 months
- Allergy, hypersensitivity, or significant adverse reaction to insulin
- Currently taking insulin for Type I or Type II diabetes
- Pregnant or breastfeeding
- Any other clinically relevant condition posing a safety risk as determined by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130
Actively Recruiting
Research Team
M
Meghan E O'Brien, MPH
CONTACT
B
Bethany K Crouse, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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