Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 7-30 days after injury

• Injury level ≥T2 (thoracic level)

• American Spinal Injury Association Impairment Scale (AIS) A-C

• Exhibits at least one of the following hypotensive symptoms:

‣ Baseline hypotension - resting supine or seated SBP \< 90mmHg;

⁃ SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;

⁃ Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting.

Locations
United States
New Jersey
Kessler Foundation
RECRUITING
West Orange
Contact Information
Primary
LeighAnn Martinez, BA
lmartinez@kesslerfoundation.org
(973)324-3557
Backup
Einat Engel-Haber, MD
ehaber@kesslerfoundation.org
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 12
Treatments
Active_comparator: Optimal stimulation (for a blood pressure response)
Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.
Sham_comparator: Sham stimulation
Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.
Sponsors
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov