Spinal Cord Injury
Conditions
Keywords
Blood pressure, Orthostatic hypotension, Transcutaneous stimulation, Cardiovascular disease
Brief summary
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Detailed description
Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.
Interventions
DEVICEDS8R
transcutaneous stimulation of the spinal cord.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to which stimulation parameters they are receiving.
Intervention model description
All participants will complete transcutaneous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-130 mmHg.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* above the age of 18 years old * individuals with traumatic spinal cord injuries at or above T6 * duration of injury if more than 1 year * non-ambulatory * American spinal injury association scale A, B or C * able to provide consent * non-ventilator * hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
Exclusion criteria
* acute illness or infection * documented history of controlled or uncontrolled diabetes * any other neurological disease other than spinal cord injury * cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke) * present of history of thrombosis in the last 12 months, severe contractures * pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seated Systolic Blood Pressure | From enrollment to the end of the last study visit, approximately 30 days. | Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg. |
Countries
United States
Participant flow
Recruitment details
10 potential participants were screened and enrolled between June 2022 and December 2023.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving Spinal Cord Stimulation to Increase and Stabilize Systolic Blood Pressure Demographic, ethnic and spinal cord injury-specific characteristics of the participants enrolled in the trial | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Hypertension at screening | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Participants Receiving Spinal Cord Stimulation to Increase and Stabilize Systolic Blood Pressure |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 15.8 |
| AIS classification of injury AIS A | 4 Participants |
| AIS classification of injury AIS B | 4 Participants |
| AIS classification of injury AIS C | 2 Participants |
| Neurological level of spinal cord injury Cervical | 7 Participants |
| Neurological level of spinal cord injury Thoracic | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
| Time since injury | 15.9 years STANDARD_DEVIATION 16.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Seated Systolic Blood Pressure
Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
Time frame: From enrollment to the end of the last study visit, approximately 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Stimulation | Seated Systolic Blood Pressure | 86 mmHg | Standard Deviation 16.6 |
| T7/8 | Seated Systolic Blood Pressure | 100.4 mmHg | Standard Deviation 13.9 |
| T9/10 | Seated Systolic Blood Pressure | 102.7 mmHg | Standard Deviation 13.2 |
| T11/12 | Seated Systolic Blood Pressure | 101.3 mmHg | Standard Deviation 11.8 |
| L1/2 | Seated Systolic Blood Pressure | 102.1 mmHg | Standard Deviation 13.5 |