Clinical trial NCT06000592: Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
Official title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Spinal Cord Injury
Spinal Cord Injuries
Neuromodulation
Traumatic Spinal Cord Injury
Spinal Cord Stimulation
SCI - Spinal Cord Injury
Blood Pressure
Blood Pressure Disorders
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.

Detailed description: Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction.

Eligibility criteria: Inclusion Criteria:

* Newly injured patients with traumatic SCI
* Admitted to Acute Inpatient Rehabilitation at Mount Sinai
* Within one year of SCI
* Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
* Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
* Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
* At least 14 years old

Exclusion Criteria:

* Implanted brain/spine/nerve stimulators
* Cochlear implants
* Cardiac pacemaker/defibrillator, or intracardiac lines
* Open skin lesions on or near the electrode placement sites (neck, upper back)
* Significant coronary artery or cardiac conduction disease
* Recent history of myocardial infarction
* Insufficient mental capacity to understand and independently provide consent
* Pregnancy
* Cancer
* Deemed unsuitable by study physician

Primary outcomes:
measure: The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
timeFrame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
measure: The safety (#1) of TSCS to improve autonomic control following acute SCI.
timeFrame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
measure: The safety (#2) of TSCS to improve autonomic control following acute SCI.
timeFrame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Secondary outcomes:
measure: The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
timeFrame: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: The Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas N Bryce, MD
role: STUDY_DIRECTOR
References: