Safety of Intranasal Insulin for Spinal Cord Injury
This study is looking at whether regular insulin, given as a nasal spray, is safe for people who have had a spinal cord injury. While insulin nasal spray has been found safe in other groups, it hasn't been studied in individuals with spinal cord injury yet. This research is a first step to see if this could be a future treatment. We are recruiting up to 12 adults, aged 18 to 84, who experienced a spinal cord injury at least four months ago. Participants will use either the insulin nasal spray or a placebo (an inactive nasal spray) at home daily for up to 24 days. The main goal is to track any serious side effects or other side effects to understand the safety of this treatment.
- Study design
- This is an interventional study, not yet assigned a phase, involving up to 12 participants. It compares regular insulin nasal spray to a placebo (inactive nasal spray).
- What's involved
- Participants will administer either insulin nasal spray or a placebo at home every day for up to 24 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured at 3 weeks after starting the intervention.
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Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Leah R Hanson, PhD · PRINCIPAL_INVESTIGATOR · HealthPartners Institute
- Kimberly Byrnes, PhD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences
Who to contact
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What this trial measures
- Safety measured by number of serious adverse events (SAE) and adverse events (AE)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.