Spinal Cord InjuryPhase 3NCT02307565
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
A Phase 3 study testing Midodrine in people with Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Midodrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James J Peters VAMC
The Bronx, New York, 10468
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Midodrine, Placebo
- Keywords
- Midodrine, Blood pressure, Orthostatic hypotension, Spinal Cord Injury, Sympathetic vascular control, Cerebral blood flow velocity, Cognition function tasks, Quality of Life, MRI, fMRI
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called Midodrine or 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.
PlaceboDrug
Also called Midodrine or 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.
| Study group | Role | What they receive |
|---|---|---|
| Midodrine | Experimental | Arm 1 last 30 days. Subject will either be given midodrine or placebo to take during Arm 1. Receives: Drug: Midodrine; Drug: Placebo |
| Placebo | Placebo comparator | 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. Receives: Drug: Midodrine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Seated systolic blood pressure following midodrine administration compared to placebo.
Measured: 30 days
Secondary outcomes (3)
Cerebral Blood Flow
Middle cerebral artery blood flow velocity following midodrine administration compared to placebo.
Measured: 30 days
Hopkins Verbal Learning Test
Memory score on the Hopkins Verbal Learning Test following midodrine administration compared to placebo. Higher score is better, range from 0 to 36.
Measured: 30 days
Number of Hypertensive Events
Number of daily systolic blood pressure recordings above 140 mmHg following midodrine administration compared to placebo.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, Ed.D, Principal investigator, JJPVAMCTrevor Dyson-Hudson, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307565
- Sponsor's protocol ID
- WEC-13-066
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2014
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 33177997Wecht 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.
PubMed 32203065
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure, Cerebral Blood Flow and Cognition in SCI
- ClinicalTrials.gov ID
- NCT02307565
- Acronym / sponsor ID
- WEC-13-066
- Conditions
- Spinal Cord Injury
- Keywords
- Midodrine, Blood pressure, Orthostatic hypotension, Spinal Cord Injury, Sympathetic vascular control, Cerebral blood flow velocity, Cognition function tasks, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Foundation
- Study start
- Mar 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine | Experimental | Drug: Midodrine, Drug: PlaceboArm 1 last 30 days. Subject will either be given midodrine or placebo to take during Arm 1. |
| Placebo | Placebo comparator | Drug: Midodrine, Drug: PlaceboArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineAlso: Midodrine or PlaceboEach 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. | Drug | Midodrine, Placebo |
| PlaceboAlso: Midodrine or PlaceboEach 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. | Drug | Midodrine, Placebo |
Primary outcome
Systolic Blood Pressure
Time frame: 30 days
Seated systolic blood pressure following midodrine administration compared to placebo.
3 secondary outcomes
Cerebral Blood Flow
Time frame: 30 days
Hopkins Verbal Learning Test
Time frame: 30 days
Number of Hypertensive Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33177997Bloom 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.
- Derived from this study: PubMed 32203065Wecht 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Wecht, Ed.D principal investigator
JJPVAMC
Trevor Dyson-Hudson, MD principal investigator
Kessler Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midodrine in people with Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.