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NCT Number: NCT07384052

Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location status: Recruiting

Location contact

Bethany K Crouse, PhD

CONTACT

[email protected]

Leah R Hanson, PhD

PRINCIPAL_INVESTIGATOR

Meghan E O'Brien, MPH

CONTACT

[email protected]

651-495-6363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Regular insulin

Drug

Administered Intranasally at 76 IU

Other names: Novolin-R

0.9 % Normal Saline

Other

Placebo Control

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment adherence as assessed by participant Daily Drug Diaries

    Time frame: 3 weeks

    Number of doses successfully administered as reported by participants in their daily drug diaries

  2. Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist

    Time frame: Baseline Visit

    Average score on virtual training compliance checklist, both arms combined

  3. Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey

    Time frame: Baseline

    Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined

  4. Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist

    Time frame: Screening Visit

    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

  5. Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey

    Time frame: Screening Visit

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany K Crouse, PhD

CONTACT

[email protected]

Meghan E O'Brien, MPH

CONTACT

[email protected]

651-495-6363

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • Uniformed Services University of the Health Sciences

Registry information

Acronym: INI-SCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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