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Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

NCT06841198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries (SCI)
  • Orthostatic Hypotension, Dysautonomic
  • Cardiovascular
  • Transcutaneous Spinal Stimulation

Interventions

DEVICE

spinal cord transcutaneous stimulation

Stimulation, using the Neostim-5 (Cosyma Ltd.), a 5-channel electrical stimulator, will be administered throughout the study period, beginning shortly after the injury and continuing at regular intervals until one year post-spinal cord injury. It will be performed in two settings: 1. During seated mapping to identify stimulation sites (potentially T7/8, T11/12, L1/2, and S1/2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg. 2. During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms).

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Einat Engel-Haber, MD · Kessler Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06841198 on ClinicalTrials.gov