Orthostatic Hypotension Clinical Trials

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Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury

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

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

• 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

Locations
United States
New Jersey
Kessler Foundation
RECRUITING
West Orange
Contact Information
Primary
Leighann Martinez, BA
lmartinez@kesslerfoundation.org
(973)324-3557
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 15
Treatments
Other: Testing position and cooling modality for the ice test
As a spin-off of the main study, we aim to determine which cooling modality and body position elicit the most consistent and stable blood pressure response. To do so, we conduct a supplementary experiment involving 5 individuals with chronic SCI and 5 able-bodied controls. Each participant completes two experimental sessions: one in the supine position and one in the seated position. Within each session, participants undergo two tests, separated by a 30-minute rest period:~1. an ice-water immersion test, in which the foot is submerged in ice water for 3 minutes, and~2. an ice-wrap test, in which ice packs are applied around the foot and ankle for 3 minutes.~The order of body position and cooling modality is pseudo-randomized. Throughout each test, blood pressure is continuously recorded, and participants rate discomfort or pain at 1-minute intervals.
Other: Main study: assessing the BP changes throughout the first year post SCI
The main study recruits 5 individuals with sub-acute SCI and follows them for one year to evaluate how blood pressure responses evolve during the early post-injury period.
Sponsors
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov