Repurposing Insulin With Intranasal Administration to Improve Function After Mild Traumatic Brain Injury (INI TBI)

November 9, 2026 updated by: HealthPartners Institute

This Phase II clinical trial protocol will provide evidence as to whether IN insulin is efficacious in reducing symptoms in people seeking care for mild TBI (concussion).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has presented to a clinic/ER reporting an acute head injury (e.g., a closed head injury or blunt TBI) and presents with at least two symptoms of TBI, as defined by the listed symptoms on the Post-Concussion Symptom Scale (PCSS)
  • Subject is considered high risk for persistent post-concussion symptoms using the post-concussion symptom (PoCS) clinical decision rule
  • Subject is between ≥18 and ≤65 years of age
  • Treatment can be initiated within 5-14 days after injury, inclusive
  • Subject must be proficient in speaking English in order to comply with instructions and measures for the study
  • Subject must be able to consent
  • Female subjects of childbearing potential must have a negative pregnancy test at the baseline visit and be willing to use a medically acceptable contraceptive method for the duration of the study

Exclusion Criteria:

  • Subject's concussion or TBI resulted in loss of consciousness of > 30 minutes
  • Subject has evidence of acute intracranial hemorrhage at screening
  • Subjects has received an intranasal vaccine within 2 weeks of the date of their baseline visit
  • 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, including findings of an abnormal nasopharyngeal exam that could interfere with intranasal administration as judged by the PI, e.g., inflammation, erythema, bleeding, atrophy, septal perforation, mucosal erosion, localized infection or ulceration, polyposis.
  • 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 evidence of blast injury, electrocution injury, or significant multisystem trauma associated with the mTBI, including significant nasal trauma
  • Subject has participated in a clinical trial investigation (drug or device) within 3 months of this study.
  • Subject has an insulin allergy
  • Subject is taking insulin for Type I or Type II diabetes
  • Subject is pregnant or breast feeding
  • Subjects with nasal piercings or any physical finding in the nose that, in the opinion of the PI, would be likely to interfere with successful completion of dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose 1 - 40 IU/IN (20 IU, twice daily x 21 days)

Intranasal insulin, lower dose, 40 IU insulin, twice daily for 21 days
Drug: Insulin (Humulin)

Intranasal regular insulin
Experimental: Dose 2 - 80 IU/IN (40 IU, twice daily x 21 days)

Intranasal insulin, higher dose, 80 IU insulin, twice daily for 21 days
Drug: Insulin (Humulin)

Intranasal regular insulin
Placebo Comparator: Dose 3 - Placebo

intranasal, twice daily for 21 days
Drug: Placebo

Intranasal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Post-Concussion Symptom Scale scores (PCSS) from baseline to 21 days
Time Frame: baseline and day 21 post-intervention

The PCSS is a 22-item self-report inventory of concussion symptoms. Each symptom is rated for severity from 0 (none) to 6 (severe), giving a total score of 0 to 132; higher scores indicate greater symptom burden. Change is calculated as the Day 21 score minus the baseline score, so negative values indicate improvement. Each insulin arm (40 IU and 80 IU) is compared separately with saline, and results are reported as the difference in mean change (insulin minus saline) with a 97.5% confidence interval.
baseline and day 21 post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in time to return to normal activities by day 21
Time Frame: baseline and day 21 post-intervention

Number of days from intervention to participant-reported return to normal activities. Participants who have not reported a return to normal activities by Day 21 are censored at their last observation. Each insulin arm (40 IU and 80 IU) is compared separately with saline, and results are reported as a hazard ratio (insulin vs. saline) with a 95% confidence interval; a hazard ratio greater than 1 indicates faster return to normal activities with insulin.
baseline and day 21 post-intervention
Change in Quality of Life after Brain Injury (QOLIBRI) scores from baseline to 21 days
Time Frame: baseline and day 21 post-intervention

The QOLIBRI is a 37-item self-report measure of health-related quality of life after traumatic brain injury. The total score ranges from 0 to 100; higher scores indicate better quality of life. Change is calculated as the Day 21 score minus the baseline score, so positive values indicate improvement. Each insulin arm (40 IU and 80 IU) is compared separately with saline, and results are reported as the difference in mean change (insulin minus saline) with a 95% confidence interval.
baseline and day 21 post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HealthPartners Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bhavani Kashyap, MBBS, PhD, HealthPartners Institute Neuroscience Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A25-357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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