Intranasal Insulin for Spinal Cord Injury
(INI-SCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if insulin, commonly used for diabetes, is safe when administered as a nasal spray to individuals with a spinal cord injury. Researchers seek to evaluate its potential as a future treatment option. Participants will use either the insulin nasal spray or a placebo (an inactive spray) daily for about three weeks. The trial seeks individuals who sustained a spinal cord injury at least four months ago and can manage the nasal spray themselves or with assistance. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable regimen of medications for at least 30 days before starting. It doesn't specify if you need to stop any current medications, but you should discuss your specific situation with the study team.
Is there any evidence suggesting that intranasal insulin is likely to be safe for people with spinal cord injury?
Research has shown that using insulin as a nasal spray is safe for many people. However, it remains untested in individuals with spinal cord injuries. Previous studies suggest that when insulin is sprayed into the nose, it can reach the spinal cord and might aid recovery after an injury, indicating it could be well-tolerated.
The FDA has already approved insulin for treating diabetes, confirming its safety for that purpose. While this is encouraging, this trial represents one of the first steps to determine if using insulin this way is safe specifically for people with spinal cord injuries.12345Why do researchers think this study treatment might be promising for spinal cord injury?
Intranasal insulin is unique because it offers a novel delivery method for potentially treating spinal cord injury. Unlike traditional treatments, which might focus on surgical interventions or rehabilitative therapies, this approach uses insulin administered directly through the nose, allowing it to reach the brain and spinal cord more effectively. Researchers are excited about this treatment because insulin plays a role in nerve growth and repair, which could help improve recovery in spinal cord injury patients. This method is non-invasive and could represent a significant shift in how we address nerve damage.
What evidence suggests that intranasal insulin might be an effective treatment for spinal cord injury?
This trial will evaluate the effects of intranasal insulin on recovery from spinal cord injury. Research has shown that insulin, when administered through the nose, can reach the spinal cord and aid recovery after an injury. Studies have found that insulin helps nerve cells survive and heal after trauma. Other research indicates that this method reduces damage in brain injuries by assisting cells in waste removal and stress reduction. Although this approach hasn't been tested in people with spinal cord injuries, these findings suggest it could be promising. Overall, early positive results in related areas support the potential for intranasal insulin to aid recovery in nerve-related injuries.12367
Who Is on the Research Team?
Leah R Hanson, PhD
Principal Investigator
HealthPartners Institute
Kimberly Byrnes, PhD
Principal Investigator
Uniformed Services University of the Health Sciences
Are You a Good Fit for This Trial?
This trial is for up to 12 people who had a spinal cord injury at least 4 months ago. They must be able to use nasal spray themselves or have someone who can help them. The study excludes those with specific health conditions that the researchers haven't listed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo virtual training and baseline assessments
Treatment
Participants receive either 76 IU insulin nasal spray or placebo daily for up to 24 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal Insulin
Trial Overview
The study tests if insulin, usually used for diabetes, is safe as a nasal spray for spinal cord injury patients. Participants will either use an insulin nasal spray or a placebo daily at home for up to 24 days while their health and symptoms are monitored.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Regular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days
0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
Uniformed Services University of the Health Sciences
Collaborator
Department of Defense Congressionally Directed Medical Research Program
Collaborator
Citations
Safety and Feasibility of Intranasal Insulin in Patients With ...
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.
2.
scholar.usuhs.edu
scholar.usuhs.edu/en/projects/acute-administration-of-intranasal-insulin-to-improve-outcome-aft/Acute Administration of Intranasal Insulin to Improve ...
We and others have found that insulin delivered via an intranasal route is able to reach the spinal cord via the cerebrospinal fluid and can improve outcomes ...
Role of Insulin in Neurotrauma and Neurodegeneration
Emerging data suggests that insulin can improve neuronal survival or recovery after trauma or during neurodegenerative diseases.
Intranasal Insulin Alleviates Traumatic Brain Injury
Our results suggest that intranasal insulin can ameliorate TBI by regulating autophagy and ER stress-mediated apoptosis through the PI3K/AKT/mTOR signaling ...
Intranasal Insulin - Neuropsychiatric Disorders
In a trial evaluating the combined effectiveness of single-dose, intranasal insulin and preceding 3-day-long application of transdermal estradiol, the insulin ...
Intranasal Insulin for the Treatment of Mild Cognitive ...
No cognitive or functional benefits were observed with intranasal insulin treatment compared with placebo over a 12-month period in the primary analyses.
Distribution of insulin in trigeminal nerve and brain after ...
Our data indicates that intranasal insulin can reach cellular CNS targets along extracellular components of the trigeminal nerve.
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