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).
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 a…
Intranasal regular insulin
Intranasal saline
Arctuva estimate
Actual pay is set by the research site.
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