Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/2/2019 |
| Start Date: | March 2014 |
| End Date: | December 2019 |
| Contact: | Caitlyn Katzelnick, MS |
| Email: | ckatzelnick@kesslerfoundation.org |
| Phone: | 973-324-3581 |
Blood Pressure, Cerebral Blood Flow and Cognition in SCI
Following spinal cord injury autonomic regulation of the cardiovascular system is impaired,
which results in a variety of measurable abnormalities in blood pressure. Evidence of
causality has been documented in the general medical literature with findings of improved
cognitive function following acute increases in blood pressure using the anti-hypotensive
agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an
inverse association between blood pressure and depression suggesting that low blood pressure
may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food
and Drug Administration to treat low blood pressure in the general population. Midodrine is
not approved in the United States to treat low blood pressure in persons with spinal cord
injury. Therefore, its use in this study is investigational. The first objective is to
characterize the relationship between blood pressure, cerebral blood flow velocity and
cognitive function after a single dose of midodrine compared to placebo. Second objective is
to determine the long-term safety and efficacy of midodrine administration.
which results in a variety of measurable abnormalities in blood pressure. Evidence of
causality has been documented in the general medical literature with findings of improved
cognitive function following acute increases in blood pressure using the anti-hypotensive
agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an
inverse association between blood pressure and depression suggesting that low blood pressure
may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food
and Drug Administration to treat low blood pressure in the general population. Midodrine is
not approved in the United States to treat low blood pressure in persons with spinal cord
injury. Therefore, its use in this study is investigational. The first objective is to
characterize the relationship between blood pressure, cerebral blood flow velocity and
cognitive function after a single dose of midodrine compared to placebo. Second objective is
to determine the long-term safety and efficacy of midodrine administration.
Acute Study:The purpose of this research study is to measure a spinal cord injured
individual's blood pressure and blood flow to the brain at rest and during thinking tasks
before and after a single dose of midodrine, a drug used to treat low blood pressure (10 mg).
Eligible participants will complete 2 visits to the laboratory. Visit 1, the subject will be
given midodrine and Visit 2, the subject will be given a placebo. The order of the drug is
random.
Observational Study:The purpose of this research study is to determine how blood pressure
changes throughout the day in a spinal cord injured individual. There is no drug in this
study. This study will last about 1 month and the subject will visit the laboratory 2 times,
at the beginning and at the end of the month. The subject will be given a blood pressure
monitor and will be asked to record his/her blood pressure at least 3 times a day. The
laboratory visits will involve the participant discussing his/her monthly blood pressure
recordings and experience with blood pressure monitor.
30-Day Crossover Study: The purpose of this research study is to determine the safety and
efficacy of midodrine administration over a 30-day period of time. Midodrine is a drug
approved by the Food and Drug Administration to treat low blood pressure in the general
population. Midodrine is not approved in the United States to treat low blood pressure in
persons with spinal cord injury. Therefore, its use in this study is investigational. The
subject's participation will involve about 10 weeks and the subject will be asked to visit
the laboratory 8 times. The subject will be asked to take midodrine for the first 30 days and
after the 14 day washout period, the subject will be asked to take a placebo for 30 days. The
order of the drug will be random. The subject and the study investigators will not know which
drug the subject is receiving first and second during the 30 day-treatment phase. For visit
1,4, 5 and 8(Initial visits-start of new drug administration and Post Visits- end of new drug
administration), the subject will complete many different thinking tasks while his/her blood
pressure, heart rate and cerebral blood flow is taken. The subject will also complete quality
of life surveys, autonomic dysreflexia surveys, and will take home a blood pressure monitor
to continue to monitor blood pressure. For visit 2, 3, 6, and 7, the subject's blood
pressure, cerebral blood flow and heart rate will be measured. Subject will also complete the
autonomic dysreflexia survey.
30-Day Crossover & MRI/Functional MRI (fMRI) Study: Eligible participants will in addition to
completing the 30-Day Crossover study (procedure explained above), will also complete a
MRI/fMRI Visit 1, 4, and 8.
individual's blood pressure and blood flow to the brain at rest and during thinking tasks
before and after a single dose of midodrine, a drug used to treat low blood pressure (10 mg).
Eligible participants will complete 2 visits to the laboratory. Visit 1, the subject will be
given midodrine and Visit 2, the subject will be given a placebo. The order of the drug is
random.
Observational Study:The purpose of this research study is to determine how blood pressure
changes throughout the day in a spinal cord injured individual. There is no drug in this
study. This study will last about 1 month and the subject will visit the laboratory 2 times,
at the beginning and at the end of the month. The subject will be given a blood pressure
monitor and will be asked to record his/her blood pressure at least 3 times a day. The
laboratory visits will involve the participant discussing his/her monthly blood pressure
recordings and experience with blood pressure monitor.
30-Day Crossover Study: The purpose of this research study is to determine the safety and
efficacy of midodrine administration over a 30-day period of time. Midodrine is a drug
approved by the Food and Drug Administration to treat low blood pressure in the general
population. Midodrine is not approved in the United States to treat low blood pressure in
persons with spinal cord injury. Therefore, its use in this study is investigational. The
subject's participation will involve about 10 weeks and the subject will be asked to visit
the laboratory 8 times. The subject will be asked to take midodrine for the first 30 days and
after the 14 day washout period, the subject will be asked to take a placebo for 30 days. The
order of the drug will be random. The subject and the study investigators will not know which
drug the subject is receiving first and second during the 30 day-treatment phase. For visit
1,4, 5 and 8(Initial visits-start of new drug administration and Post Visits- end of new drug
administration), the subject will complete many different thinking tasks while his/her blood
pressure, heart rate and cerebral blood flow is taken. The subject will also complete quality
of life surveys, autonomic dysreflexia surveys, and will take home a blood pressure monitor
to continue to monitor blood pressure. For visit 2, 3, 6, and 7, the subject's blood
pressure, cerebral blood flow and heart rate will be measured. Subject will also complete the
autonomic dysreflexia survey.
30-Day Crossover & MRI/Functional MRI (fMRI) Study: Eligible participants will in addition to
completing the 30-Day Crossover study (procedure explained above), will also complete a
MRI/fMRI Visit 1, 4, and 8.
Inclusion Criteria:
Spinal Cord Injured
- Between the ages of 18-65 years old.
- Level of injury is between C1-T12
- Primarily wheelchair dependent for ambulation
- Have a spinal cord injury that is ASIA Impairment Scale (AIS) grade of A, B or C
- Injury occurred more than 1 year ago
- Low blood pressure (Systolic BP less than 110 mmHg for males, Systolic BP less than
100 mmHg for females)
- Primary language is English
- I am right handed
Exclusion Criteria:
- Currently have an illness or infection
- Severe history of AD (more than 3 symptomatic events per week, evidence of blood
pressure elevations above 140/90 mmHg,significant adverse subjective symptoms
reporting)
- Hypertension or diabetes
- History of Traumatic Brain Injury (TBI)
- Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple
sclerosis, Parkinson's disease, etc.)
- History of epilepsy or other seizure disorder
- Diagnosis of a psychiatric disorder such as post-traumatic stress disorder,
schizophrenia or bipolar disorder
- Within the past 6 months, abused illicit drugs
- Pre-screen mini mental status exam score of less than 24, as rated by the researcher
- Vision is impaired- more than 20/60 in worst eye (with prescription eyewear)
- Coronary heart and/or artery disease
- Major surgery in the last 30 days
- Pregnant
We found this trial at
2
sites
West Orange, New Jersey 07052
Principal Investigator: Trevor Dyson-Hudson, MD
Phone: 973-324-3581
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Bronx, New York 10468
Principal Investigator: Jill M Wecht, EdD
Phone: 718-584-9000
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