Cardiovascular-autonomic Research

Investigators: Jill M. Wecht, Ed.D & Caitlyn Peters, Phd

Staff: matthew maher, ms; jorge chavez, ms

 

After suffering a SCI, maintaining blood pressure is often a challenge. We are studying how SCI disrupts normal blood pressure regulation. The benefit of medications to keep blood pressure in the normal range while sitting is being evaluated. We believe that keeping blood pressure normal while seated upright should help maintain brain blood flow and improve thinking in persons with SCI.


Eligibility criteria for all studies listed below include (unless otherwise indicated):

  • Spinal Cord Injury for at least 12-months
  • Between 18-85 years of age
  • Non-ventilator dependent;
  • Any level of injury;
  • Non-ambulatory - wheelchair dependent;
  • AIS A, B, C, D grade 

Eligibility criteria for cardiovascular impairment: To determine your eligibility to participate in these cardiovascular studies you will undergo a passive sit-up test.  This involves measurement of your blood pressure and heart for 10-minutes while you rest quietly in the supine position and then for 10-minutes after you are moved into the seated position. You will be eligible for these studies if you meet one or more of the following criteria:

  • Low blood pressure
  • Males- systolic blood pressure < 110 mmHg and/or diastolic BP < 70 mmHg;
  • Females- systolic blood pressure < 100 mmHg and/or diastolic BP < 70 mmHg)
  • Orthostatic hypotension:
  • Fall in systolic blood pressure > 20 mmHg when you are moved from the supine to the seated position or
  • Fall in diastolic blood pressure > 10 mmHg when you are moved from the supine to the seated position.

Project Title: Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Veterans with Spinal Cord Injury 
Project Status: Actively enrolling
Funding Agency: VA Rehabilitation Research & Development Service (grant #R-3706)

The purpose of this study is to identify electrical stimulation parameter settings that normalize systolic blood pressure using non-invasive transcutaneous spinal cord stimulation (TSCS).  This study has two project aims and involves between 1 and 7 visits to our laboratory in the Bronx, NY.
The first visit will involve a screening, during which we will measure your blood pressure and heart rate while you are seated in your wheelchair and then again when we move you from lying down into a seated position.
Aim 1:  If you are eligible based on the criteria listed above, we will enroll you in study 1, which involves up to 4 study visits to identify TSCS parameters that normalize your blood pressure while you are seated in your wheelchair.  Study 1 visits will be conducted at least 3 days apart and will take about 3 hours.  Once we identify TSCS parameters that normalize your blood pressure you will be eligible for study 2, which involves 2 study visits to determine your blood pressure during a head-up tilt with and without TSCS. 
Aim 2: Study 2 visits involve the assessment of arterial stiffness by placing a small pencil like probe against your neck at the carotid artery and against your thigh at the femoral artery while you are lying down.  Then you will undergo a 60°head-up tilt for 30 minutes.  Blood pressure and heart rate will be continuously monitored and we will draw a blood sample while you are lying down and at 60° tilt. Study 2 visits will take about 3 hours and will be scheduled no less than 3 days apart.
Participants: Between 8 and 10 individuals with SCI who meet criteria listed above.
Time Commitment: about 3 hours/visit; 1-7 visits over 2 months
Reimbursement: 
$100/visit; $100-$700 stipend


Project Title: Autonomic Effects of Transcutaneous Spinal Cord Stimulation
Project Status: Actively enrolling
Funding Agency: VA Rehabilitation Research & Development Service (grant #R-4373)

The purpose of this study is to determine the effects of TSCS induced normalization of systolic blood pressure on exercise endurance and recovery and on core body temperature responses to cool environmental exposure.  This study has two project aims and involves between 1 and 8 visits to our laboratory in the Bronx, NY.
Aim 1:  If you are eligible based on the criteria listed above, we will enroll you in study 1, which involves 2 study visits to determine your heart rate responses during and following a 30-minute arm cycle exercise (ACE) test. On each of the 2 study visits you will perform the ACE test, on one visit you will have active TSCS to normalize your blood pressure and on the other visit you will perform the ACE test without TSCS.  You will not know which visit you are receiving active TSCS.  These study visits will be conducted at least 3 days apart and will take about 3 hours. 
Aim 2: Study 2 involves 2 study visits to determine your core body temperature and your thermal comfort levels in response to 90-minutes of sitting in a cool (18°C; 64°F) room.  You will have active TSCS to normalize your blood pressure and on the other visit you will be tested without TSCS.   You will not know which visit you are receiving active TSCS.  These study visits will be conducted at least 3 days apart and will take about 3 hours. 

Participants: 20 individuals with SCI who meet eligibility criteria listed above.
Time Commitment: about 3 hours/visit; 1-8 visits over 2 months
Reimbursement: 
$100/visit; $100-$800 stipend


Project Title: The association between blood pressure dysregulation and health-related quality of life in people with spinal cord injury
Project Status: To begin enrolling May 2023
Funding Agency: Craig H. Neilsen Foundation (grant #857745)

This study aims to determine the relationship between your blood pressure, taken in the laboratory and during your daily activities, and measures of your life, activities, and mood. This study involves one in-person study visit, during which your blood pressure will be recorded while you complete several surveys about your life, daily activities, and mood. Then you will be sent home with a blood pressure monitor and will be asked to record your blood pressure every two hours during the day and once each night for 7 days. You will also be prompted by a mobile app on your phone to answer questions about symptoms, mood, sleep and activities four times each day. After the 7 days, your study participation is over and we will give you a pre-addressed, stamped envelope to return the blood pressure monitor.

Participants: 30 individuals with SCI, T6 and above.  In addition, to be eligible you will need to have daily access to a smart phone (Iphone/Android) and not currently prescribed any blood pressure medication.
Time Commitment: One 2 hour visit plus home blood pressure monitoring for a week
Reimbursement: 
In-person visit $40; $10/day for home monitoring ($70); $10 for returning the blood pressure monitor: Total $120 stipend


Project Title: Feasibility, reliability, and long-term prognostic capability of the International Standards to document Autonomic Function after Spinal Cord Injury (ISAFSCI) during acute inpatient rehabilitation.
Project Status: Actively enrolling
Funding Agency: National Institute for Disability, Independent Living & Rehabilitation Research (grant #90SIMS0003)

There are no standard of care guidelines regarding the clinical management of autonomic nervous system (ANS) dysfunction in newly injured individuals with SCI, and as such, clinicians spend a substantial amount of time addressing a multitude of autonomic issues during acute inpatient rehabilitation (AIR).  As such an international collaboration of scientists and clinicians developed the International Standards to document Autonomic Function following SCI (ISAFSCI); however, routine use of the ISAFSCI is not part of clinical practice in patients with SCI during AIR.  Due to the multitude of adverse impacts of long-term ANS impairment on health, physical function, and quality of life, use of the ISAFSCI during AIR should be considered a high priority.
The goals of this project are to determine the feasibility of administering the ISAFSCI within 7 days of discharge from AIR, and to assess levels of life satisfaction and participation in daily activities at the 12-month follow-up in relation to ISAFSCI score at discharge.
Participants: 180 newly injured individuals with SCI who are inpatients for rehabilitation after injury.  Recruitment for this study is ongoing at the Mount Sinai Hospital, the University of Miami, the University of Minnesota, and the Mayo Clinic.
Time Commitment: 1 visit for about 1 hour
Reimbursement: 
None


Project Title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients with Spinal Cord Injury  
Project Status: Actively enrolling
Funding Agency: National Institute for Disability, Independent Living & Rehabilitation Research (grant #90SIMS0003)

Many people who recently injured their spinal cord have trouble maintaining blood pressure which results in rapid increases or decreases in blood pressure during daily activities. In this study we will use electric stimulation of the spinal cord with Transcutaneous Spinal Cord Stimulation (TSCS). Transcutaneous means that the stimulation is applied to the skin using sticky pads (electrodes) that are placed on the skin above the spine at a few sites on your back. Using TSCS we will try to stabilize your blood pressure within a target blood pressure range while you are seated in a wheelchair. We will also study the effects of TSCS on your blood pressure during your prescribed therapy sessions and the effect of stable blood pressure on blood flow to your brain.

The primary goal of this trial is to determine the safety and feasibility of using TSCS to promote a stable blood pressure within a target range, which is defined in males as systolic BP 110-130 mmHg and in females as 100-130 mmHg, during AIR in newly injured patients with traumatic SCI. The secondary goals are to determine the immediate efficacy of active TSCS to stabilize blood pressure and improve cerebral blood flow and reduce symptoms of orthostatic intolerance (dizziness, lightheadedness, nausea, blurry vision, etc.) in response to a bedside sit-up test.

Participants: 50 newly injured individuals with SCI who are inpatients for rehabilitation after injury.  Recruitment for this study is ongoing at the Mount Sinai Hospital.
Time Commitment: Depends on the length of inpatient stay.
Reimbursement: 
None