Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tilt test with stimulation (real-time effects): Intervention 1, 20 sessions of stimulation (Intervention 2).
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects
Overview
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
- Device Tilt 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. - Device 20 sessions of stimulation (Intervention 2)
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
Primary outcome measures
- Systolic blood pressure [Time frame: 1 month]
- Systolic blood pressure [Time frame: Through study completion, an average of 5 months]
Secondary outcome measures (6)
- duration in tilt test [Time frame: Through study completion, an average of 5 months]
- Orthostatic symptoms questionnaire [Time frame: Through study completion, an average of 5 months]
- 24-hour ABPM OH events - taken at home [Time frame: Through study completion, an average of 5 months]
- Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores [Time frame: Through study completion, an average of 5 months]
- Spinal cord injury - quality of life scores [Time frame: Through study completion, an average of 5 months]
- Canadian Occupational Performance Measure scores [Time frame: Through study completion, an average of 5 months]
Eligibility criteria
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:
- Persistent hypotension (SBP < 90mmHg)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kessler Foundation — West Orange
Identifiers
NCT: NCT07674511 · R-1323-26 · 1R03HD120505-01