Clinical trial NCT06841198: Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Official title: Assessing Cardiovascular Effects: is There a Time Too Early for Spinal Stimulation in Acute SCI? a Year-Long Evaluation of Autonomic Function Following Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Orthostatic Hypotension, Dysautonomic
Cardiovascular
Transcutaneous Spinal Stimulation
Keywords: Transcutaneous Spinal Cord Stimulation
spinal cord stimulation
orthostatic hypotension
blood pressure
cardiovascular
neuromodulation
acute spinal cord injury
chronic spinal cord injury
inpatient rehabilitation
tilt testing
cold pressor test
ambulatory blood pressure monitoring
autonomic dysfunction following spinal cord injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure.

The main questions are:

How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year?

The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.

Detailed description: This clinical study investigates the cardiovascular effects of spinal cord transcutaneous stimulation (scTS) in individuals with recent spinal cord injury (SCI), examining how blood pressure response to stimulation evolves over the first year post-injury. The primary objectives are to determine the optimal timing for initiating scTS for cardiovascular control, characterize blood pressure response evolution to stimulation over one year, and assess autonomic activation patterns through multiple testing methods.

The study will recruit five individuals with recent SCI, specifically targeting those who are 50 days or less post-injury, with an injury level at or above T6, and classified as American Spinal Injury Association Impairment Scale (AIS) A/B. All participants must present with low blood pressure and orthostatic hypotension and be between 18-75 years of age.

The study protocol is divided into inpatient and outpatient phases. During the inpatient phase, consisting of 5-11 sessions, participants undergo a basic assessment including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor testing, and tilt tests with and without stimulation. The protocol also includes 2-3 days of stimulation mapping.

The outpatient phase spans 15-18 sessions over the remainder of the year. Participants undergo monthly mapping sessions and autonomic dysfunction assessments, with comprehensive autonomic testing conducted at 6, 9, and 12 months post-injury. Throughout both phases, researchers perform stimulation mapping across various spinal segments (thoracic, lumbosacral) using a 5-channel electrical stimulator, while monitoring blood pressure and electromyography to target a blood pressure range of 110-120 mmHg.

The study employs multiple assessment tools, including 70° tilt tests with orthostatic symptom evaluation every 5 minutes, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring.

The study aims to track primary outcomes including blood pressure response to stimulation at different time points, evolution of orthostatic hypotension symptoms and management, and the pattern of autonomic dysfunction development post-injury.

Eligibility criteria: Inclusion Criteria:

* Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
* Between 18-75 years old
* 7-50 days after injury
* Injury level ≥ T6 (a cervical or a high-level chest injury)
* Individuals experiencing low blood pressure after the injury
* American Spinal Injury Association Impairment Scale (AIS) A or B

Exclusion Criteria:

* A ventilator is needed for breathing.
* Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
* There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
* A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
* There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
* There is a history of seizures.
* Pregnancy.

Primary outcomes:
measure: Systolic blood pressure in seated mapping sessions
timeFrame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
measure: systolic blood pressure in a 70 degree tilt
timeFrame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
Secondary outcomes:
measure: cold pressor test
timeFrame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
measure: 24-hour ambulatory blood pressure monitoring
timeFrame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
measure: An autonomic dysfunction following spinal cord injury questionnaire
timeFrame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Einat Engel-Haber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engel-Haber E, Bheemreddy A, Bayram MB, Ravi M, Zhang F, Su H, Kirshblum S, Forrest GF. Neuromodulation in Spinal Cord Injury Using Transcutaneous Spinal Stimulation-Mapping for a Blood Pressure Response: A Case Series. Neurotrauma Rep. 2024 Sep 20;5(1):845-856. doi: 10.1089/neur.2024.0066. eCollection 2024.