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Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02307565
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Midodrine Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Blood Pressure, Cerebral Blood Flow and Cognition in SCI
Study Start Date : March 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Midodrine
Arm 1 last 30 days. Subject will either be given midodrine or placebo to take during Arm 1.
Drug: Midodrine
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 Name: Midodrine or Placebo

Drug: Placebo
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 Name: Midodrine or Placebo

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.
Drug: Midodrine
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 Name: Midodrine or Placebo

Drug: Placebo
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 Name: Midodrine or Placebo




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Up to 3 years ]
    Seated systolic blood pressure following midodrine administration compared to placebo.


Secondary Outcome Measures :
  1. Cerebral Blood Flow [ Time Frame: Up to 3 years ]
    Middle cerebral artery blood flow velocity following midodrine administration compared to placebo.

  2. Memory [ Time Frame: Up to 3 years ]
    Memory score on the Hopkins Verbal Learning Test following midodrine administration compared to placebo.

  3. Number of Hypertensive Events [ Time Frame: Up to 3 years ]
    Number of daily blood pressure recordings above 140/90 mmHg following midodrine administration compared to placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307565


Contacts
Contact: Caitlyn Katzelnick, MS 973-324-3581 ckatzelnick@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Caitlyn Katzelnick, MS    973-324-3581    ckatzelnick@kesslerfoundation.org   
Contact: Alex T Lombard, MS    973-324-3581    ALombard@kesslerfoundation.org   
Principal Investigator: Trevor Dyson-Hudson, MD         
United States, New York
James J Peters VAMC Recruiting
Bronx, New York, United States, 10468
Contact: Sana Saeed, BS    718-584-9000 ext 5184    Sana.Saeed@va.gov   
Contact: Nhuquynh D Nguyen, BS    (718) 584-9000 ext 1732    Nhuquynh.Nguyen@va.gov   
Principal Investigator: Jill M Wecht, EdD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Foundation
Investigators
Principal Investigator: Jill M Wecht, Ed.D JJPVAMC
Principal Investigator: Trevor Dyson-Hudson, MD Kessler Foundation

Responsible Party: Jill M. Wecht, Ed.D., Research Health Scientist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02307565     History of Changes
Other Study ID Numbers: WEC-13-066
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center:
Midodrine
Blood pressure
Orthostatic hypotension
Spinal Cord Injury
Sympathetic vascular control
Cerebral blood flow velocity
Cognition function tasks
Quality of Life
MRI
fMRI

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action