Neuromodulation in Spinal Cord Injury Using Transcutaneous Spinal Stimulation-Mapping for a Blood Pressure Response: A Case Series.
Einat Engel-Haber, Akhil Bheemreddy, Mehmed Bugrahan Bayram...
https://pubmed.ncbi.nlm.nih.gov/39391052Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06841198
Assessing Cardiovascular Effects of Spinal Cord Transcutaneous Stimulation A Year-Long Evaluation of Autonomic Function Following Acute Spinal Cord Injury
Led by Kessler Foundation · Updated on 2025-09-05
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how cardiovascular function changes during the first year after a spinal cord injury (SCI), focusing on how blood pressure responds to spinal cord transcutaneous stimulation (scTS). This study aims to identify the best timing to start stimulation for controlling blood pressure and to understand how autonomic nervous system activity evolves after injury. The study targets individuals recently injured (50 days or less), with injuries at or above the T6 spinal level, classified as AIS A or B, who experience low blood pressure and orthostatic hypotension. The study involves two phases: inpatient and outpatient. During the inpatient phase, participants have 5-11 sessions that include assessments like autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor tests, and tilt tests with and without scTS. They also undergo 2-3 days of stimulation mapping using a Neostim-5 device to find stimulation sites and parameters for maintaining blood pressure between 110-120 mmHg. The outpatient phase includes 15-18 sessions over the rest of the year, with monthly mapping and autonomic assessments and detailed testing at 6, 9, and 12 months post-injury. Participants will attend approximately 20-29 sessions throughout the year, starting during inpatient rehabilitation and continuing as outpatients. Researchers will monitor blood pressure during seated mapping and tilt tests, evaluate symptoms of orthostatic hypotension, and assess autonomic function with questionnaires and cold pressor tests. Blood pressure monitoring and stimulation mapping occur regularly, with the main outcome being systolic blood pressure changes during stimulation. Safety and cardiovascular responses will be closely tracked during the full year following injury.
CONDITIONS
Brief Title
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Age between 18 and 75 years
- Injury occurred 7 to 50 days before enrollment
- Spinal cord injury level at or above T6
- Experiencing low blood pressure after injury
- Classified as American Spinal Injury Association Impairment Scale (AIS) A or B
You will not qualify if you...
- Requires a ventilator for breathing
- Has implanted devices such as brain/spine/nerve stimulators, cardiac pacemaker/defibrillator, or intra-cardiac lines
- Has significant vascular or heart signal diseases or recent heart attack
- Started new medication for blood pressure or heart issues within last 5 days (except midodrine)
- Has active infection or current illness interfering with study (e.g., urinary tract infection, recent blood clots, pressure injury)
- History of seizures
- Is pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Inpatient Treatment
Duration - Approximately 1 to 2 weeks
Participants undergo multiple assessments and spinal cord transcutaneous stimulation sessions during inpatient rehabilitation. This includes autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor tests, tilt tests with and without stimulation, and stimulation mapping to identify optimal stimulation sites and parameters.
5 to 11 sessions over the inpatient stay
Outpatient Treatment
Duration - Up to 11 months
Participants continue with regular spinal cord transcutaneous stimulation mapping and autonomic assessments in an outpatient setting. Monthly mapping sessions and questionnaires are conducted, with comprehensive autonomic testing at 6, 9, and 12 months post-injury to monitor cardiovascular responses and autonomic function.
15 to 18 sessions approximately monthly
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
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Research Team
L
Leighann Martinez, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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