- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02893553
The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study 1: Subjects will visit the laboratory between 3 and 9 times for 4 hours to determine the BP response to each dose of the 3 study medications (midodrine, pyridostigmine, and mirabegron). Upon arrival to the laboratory subjects will be randomized to receive midodrine, pyridostigmine, or mirabegron. Subjects will remain seated in their wheelchair for the duration of testing. Instrumentation will be applied by study personnel while subject is seated quietly, this can take up to 20 minutes. Instrumentation includes placement of 3 ECG electrodes for continuous HR monitoring and finger and brachial BP cuffs. BP, BR and HR will be recorded for 5-minutes before medication administration (baseline). After baseline, a small pill will be given with a glass of water. BP, BR and HR will be monitored for 5-minutes every 30 minutes for 4 hours after drug administration.
Study 2: Twenty will visit the laboratory on 4 occasions to determine the effects of three anti-hypotensive agents, compared to placebo, on BP, CBFv, and cognitive performance on selected neuropsychological tests. Upon arrival to the laboratory for every visit subjects will be randomized to receive midodrine, pyridostigmine, mirabegron, or matching placebo. Neither the study subject nor the investigator will know which is being administered. Subjects will remain seated in their wheelchair throughout the duration of the study session and will be closely monitored by study personnel. Instrumentation will include placement of 3 ECG electrodes for continuous heart rate (HR) monitoring, finger and brachial BP cuffs, and a Doppler ultrasound probe positioned at the left MCA for continuous CBFv monitoring. Subjects will remain quietly seated in their wheelchair for 30-minutes after instrumentation for a 5-minute recording of continuous HR, BP, and CBFv (baseline). Prior to the baseline data collection period, the first battery of cognitive tests will be administered. The study medication will be administered to the subject along with a glass of water approximately 30-minutes after arrival to the laboratory. There will be a 2 hour break period until the second cognitive battery begins.
Study Type
Enrollment (Actual)
Phase
- Phase 2
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
- Any level of injury
- Any ASIA grade of SCI
- Primarily wheelchair dependent for mobility
- Duration of injury ˃ 1 year
Exclusion Criteria:
- Current illness or infection
- History of severe autonomic dysreflexia (AD: condition where BP increases)
- More than 3 symptomatic events per week; BP elevations above 140/90 mmHg; adverse symptoms reporting (e.g., light headedness, dizziness, goosebumps, chills, nausea, etc.)
- Diagnosis of hypertension
- History of Traumatic Brain Injury (TBI)
- Documented 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
- Liver or kidney disease
- Bladder problems including blockage of the urine and/or weak urine stream
- Diagnosis of a psychiatric disorder such as schizophrenia or bipolar disorder
- Diagnosis of artery disease, heart failure, irregular heartbeat, and AV block
- Allergies to aspirin, a yellow dye, pyridostigmine bromide, midodrine hydrochloride, lyethylene oxide, polyethylene glycol, hydroxypropyl cellulose, butylated hydroxytoluene, magnesium stearate, hypromellose, yellow ferric oxide, and red ferric oxide
- Had major surgery in the last 30 days
- Illicit drug abuse within the last 6 months
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study 1
Study 1: is a dose escalation to determine the individualized dose of each of 3 medications (midodrine, pyridostigmine, mirabegron) that increases SBP into the normal range (111-139 mmHg).
The investigator will be using midodrine hydrochloride, pyridostigmine bromide and mirabegron.
|
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
Other Names:
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
Other Names:
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
|
Experimental: Study 2
Study2: is a randomized placebo-controlled double-blinded investigation to determine the effect of the normalization of SBP on cerebral blood flow, cognitive function (memory and attention processing) and quality of life.
The investigator will be using midodrine hydrochloride, pyridostigmine bromide, mirabegron and placebo.
|
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
Other Names:
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
Other Names:
study 1 will be single blind.
study 2 will be blinded randomized-control trial.
placebo will only be used for study arm 2, the randomized blinded phase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: Up to 5 years
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Seated systolic blood pressure following intervention administration.
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Up to 5 years
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Cerebral Blood Flow
Time Frame: Up to 5 years
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Middle cerebral artery blood flow velocity following intervention administration compared to placebo.
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Up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jill M Wecht, Ed.D, James J. Peters VA Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Autonomic Nervous System Diseases
- Wounds and Injuries
- Hypotension
- Spinal Cord Injuries
- Autonomic Dysreflexia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Urological Agents
- Enzyme Inhibitors
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anticonvulsants
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Cholinesterase Inhibitors
- Adrenergic beta-3 Receptor Agonists
- Adrenergic alpha-1 Receptor Agonists
- Bromides
- Mirabegron
- Midodrine
- Pyridostigmine Bromide
Other Study ID Numbers
- WEC-16-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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