Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury

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

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

• 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:

‣ Baseline hypotension - resting supine or seated systolic blood pressure(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: 2023-02-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 5
Treatments
Experimental: Participants with a chronic SCI (≥ 6 months after injury)
Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation)
Sponsors
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov