Clinical trial NCT05725499: The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
Official title: Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Hypotension
Orthostatic Hypotension
Spinal Cord Diseases
Cardiovascular Diseases
Trauma, Nervous System
Central Nervous System Diseases
Nervous System Diseases
Blood Pressure
Keywords: Transcutaneous Spinal Cord Stimulation
Spinal Stimulation
Orthostatic Hypotension
Blood Pressure
Neuromodulation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2023-02-13
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: This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).

The main questions it aims to answer are:

1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?
2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?

Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

Detailed description: Cardiovascular (CV) control in persons with a high level (thoracic level T6 or above) spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Orthostatic hypotension (OH), a significant decrease in blood pressure (BP) when moving from lying flat (supine) to an upright position, appears early after injury and is frequently accompanied by dizziness, weakness, fatigue, and even syncope. In the long term, while symptoms are typically diminished, it still clinically occurs in 50% of individuals with a cervical injury. The physical, social, and emotional consequences of OH pose a major issue. Moreover, BP instability is associated with a decline in CV health and somewhat accounts for the 3 to 4-fold increased risk for stroke and heart disease in this clinical population.

In recent years, epidural spinal cord stimulation has been explored with promising results as a potential treatment for CV dysfunction. Spinal cord transcutaneous stimulation (scTS) represents an alternate approach, with the potential to benefit more people with fewer risks. Only one study thus far successfully applied scTS to restore CV function and resolve orthostatic symptoms following SCI, with stimulation applied at one thoracic location.

The objective of this study is to investigate the effect of scTS on BP in individuals with chronic SCI who experience OH. Stimulation sites and parameters that consistently increase and stabilize systolic BP within the range of 110-120 mmHg, during an orthostatic provocation (a 70° tilt-test), will be sought. The investigators will also evaluate whether there is any change in the BP response following repeated stimulation sessions. This project will provide the foundational evidence to use scTS to improve autonomic function in various SCI populations and help overcome barriers to engagement in activity and participation imposed by autonomic dysfunction.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury for greater than or equal to 6 months
* Injury level ≥ T6 (thoracic level)
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
* Exhibits at least one of the following hypotensive symptoms:

  1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
  2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
  3. Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting

Exclusion Criteria:

* Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
* 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
* Insufficient mental capacity to understand and independently provide consent
* Pregnancy
* Cancer
* Deemed unsuitable by study physician

Primary outcomes:
measure: Optimal stimulation sites
timeFrame: Through Mapping and testing sessions, average of 3 weeks
measure: Optimal stimulation frequency
timeFrame: Through Mapping and testing sessions, average of 3 weeks
measure: Systolic blood pressure - efficacy of stimulation
timeFrame: Throughout the experiment, average of 6 weeks
measure: Systolic blood pressure - effect of training
timeFrame: Post training, average of 2 weeks
measure: Orthostatic symptoms questionnaire
timeFrame: Throughout the experiment, average of 6 weeks
Secondary outcomes:
measure: EMG of leg muscles - muscle activation (analysis of mean and peak amplitudes)
timeFrame: Through Mapping and testing sessions, average of 3 weeks
measure: Spinal Cord Injury-Quality of Life (SCI-QOL) questionnaires
timeFrame: Before the first session and after the last session, average of 6 weeks
measure: Global response assessment (GRA)
timeFrame: post training, average of 6 weeks
measure: Additional hemodynamic measure - diastolic blood pressure
timeFrame: throughout the trial, average of 6 weeks
measure: Additional hemodynamic measure - heart rate
timeFrame: throughout the trial, average of 6 weeks
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Gail F Forrest, Phd
role: PRINCIPAL_INVESTIGATOR
References: