Blood Pressure, Cardiovascular Diseases, Central Nervous System Disease, Hypotension, Nervous System Diseases, Orthostatic Hypotension, Spinal Cord Diseases, Spinal Cord Injuries, Trauma, Nervous System
Conditions
Keywords
transcutaneous spinal cord stimulation, spinal stimulations, orthostatic hypotension, blood pressure, neuromodulation
Brief summary
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury. The main questions this study attempts to solve: 1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
Detailed description
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
Interventions
DEVICETilt test with stimulation (real-time effects): Intervention 1
While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.
DEVICE20 sessions of stimulation (Intervention 2)
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
Sponsors
Kessler Foundation
Montclair State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with a SCI ≥ 1 year after injury * Injury level ≥ T6 (thoracic level) * AIS grade A-C * Cardiovascular dysfunction characterized by one or more of the following: 1. Persistent hypotension (SBP \< 90mmHg) 2. Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning). Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.
Exclusion criteria
* Current illness (e.g., infection, a pressure injury that might interfere with the intervention) * Ventilator-dependent * History of implanted brain/spine/nerve stimulators * Cardiac pacemaker/defibrillator or intra-cardiac lines * Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction * History of seizures * pregnancy * Insufficient mental capacity to understand and independently provide consent * Deemed unsuitable by the study physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 1 month | Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration in tilt test | Through study completion, an average of 5 months | how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table) |
| Orthostatic symptoms questionnaire | Through study completion, an average of 5 months | A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity. |
| 24-hour ABPM OH events - taken at home | Through study completion, an average of 5 months | Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities and their time-points. Conducted before, halfway through, and after the intervention |
| Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores | Through study completion, an average of 5 months | 24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events |
| Spinal cord injury - quality of life scores | Through study completion, an average of 5 months | A questionnaire was developed to address the shortage of psychometrically sound and relevant patient-reported outcome measures for clinical care and research in SCI rehabilitation |
| Canadian Occupational Performance Measure scores | Through study completion, an average of 5 months | A semi-structure interview where the individual identifies and measures their areas of difficulty, scoring their performance on the tasks and their satisfaction with their ability |
Countries
United States
Contacts
CONTACTLeighAnn Martinez, BA
CONTACTEinat Engel-Haber, MD
PRINCIPAL_INVESTIGATORGail F Forrest, PhD
Kessler Foundation
Outcome results
None listed