- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02307565
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
Blood Pressure, Cerebral Blood Flow and Cognition in SCI
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New Jersey
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West Orange, New Jersey, United States, 07052
- Kessler Foundation Research Center
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New York
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Bronx, New York, United States, 10468
- James J Peters VAMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Midodrine
Arm 1 last 30 days.
Subject will either be given midodrine or placebo to take during Arm 1.
|
Each arm (2) will last 30 days with a 14 day washout in between each arm.
Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days).
The subjects will take a pill three times a day.
Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Other Names:
Each arm (2) will last 30 days with a 14 day washout in between each arm.
Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days).
The subjects will take a pill three times a day.
Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Other Names:
|
Placebo Comparator: Placebo
Arm 2 is followed by a 14 day washout period.
Arm 2 last 30 days.
Subject will be given a drug (placebo or midodrine) to take during Arm 2.
|
Each arm (2) will last 30 days with a 14 day washout in between each arm.
Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days).
The subjects will take a pill three times a day.
Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Other Names:
Each arm (2) will last 30 days with a 14 day washout in between each arm.
Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days).
The subjects will take a pill three times a day.
Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: Up to 3 years
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Seated systolic blood pressure following midodrine administration compared to placebo.
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Blood Flow
Time Frame: Up to 3 years
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Middle cerebral artery blood flow velocity following midodrine administration compared to placebo.
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Up to 3 years
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Memory
Time Frame: Up to 3 years
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Memory score on the Hopkins Verbal Learning Test following midodrine administration compared to placebo.
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Up to 3 years
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Number of Hypertensive Events
Time Frame: Up to 3 years
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Number of daily blood pressure recordings above 140/90 mmHg following midodrine administration compared to placebo.
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Up to 3 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jill M Wecht, Ed.D, JJPVAMC
- Principal Investigator: Trevor Dyson-Hudson, MD, Kessler Foundation
Publications and helpful links
General Publications
- Bloom O, Wecht JM, Legg Ditterline BE, Wang S, Ovechkin AV, Angeli CA, Arcese AA, Harkema SJ. Prolonged Targeted Cardiovascular Epidural Stimulation Improves Immunological Molecular Profile: A Case Report in Chronic Severe Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 15;14:571011. doi: 10.3389/fnsys.2020.571011. eCollection 2020.
- Wecht JM, Weir JP, Katzelnick CG, Chiaravalloti ND, Kirshblum SC, Dyson-Hudson TA, Weber E, Bauman WA. Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI. Spinal Cord. 2020 Sep;58(9):959-969. doi: 10.1038/s41393-020-0448-0. Epub 2020 Mar 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Adrenergic alpha-1 Receptor Agonists
- Midodrine
Other Study ID Numbers
- WEC-13-066
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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