Intranasal Insulin and Post-stroke Cognition: A Pilot Study
Stroke
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Ischemic stroke and measurable deficit on the initial NIHSS (> 1)
- Cognitive impairment within the 5th and 50th percentiles for age, race, and education based on Montreal Cognitive Assessment (MoCA) or 2 out of 5 delayed recall or less on the MoCA.
- Able to sign informed consent, have a caregiver, and live within a reasonable driving distance from Wake Forest Baptist Medical Center.
Exclusion Criteria:
- Patients under age 40 or 90 years or older
- Living in skilled nursing facility
- Severe stroke deficits at 4 weeks that prohibit participation in cognitive testing (global or receptive aphasia, or severe expressive aphasia)
- Diabetes requiring insulin
- Psychiatric disorders
- Severe head trauma
- Alcoholism
- Neurologic disorders other than stroke
- Renal disease
- hepatic disease
- chronic obstructive pulmonary disease
- unstable cardiac disease
- those with prior deficits in ADLs and IADLs
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intranasal Insulin
Intranasal Saline
Intranasal Insulin (20 IU BID): Humulin insulin packaged is in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.
Intranasal saline: Saline is packaged in single-dose ampules and inserted into the VianaseTM chamber. Ampoules are dispensed in 3 week supplies per study visit. Patients/caregivers, investigators, and outcome assessors are masked to group assignment. Subjects will receive their first dose in clinic, and wait 2 hrs to determine any adverse effects of inhaled dose. Glucose levels will be measured to monitor for hypoglycemia and documented. All subjects will check peak dose blood sugar levels with glucometer, 3 times per week during insulin treatment.