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Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

Study acronym: SCI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 2, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Aug 2024 to Aug 2026
    • Start date changed from estimate of Jun 2023 to Dec 1, 2023
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  3. Notable Start date: Apr 2023 to Jun 2023v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05731986
Lead Sponsor Kessler Foundation
Conditions
(from sponsor)
Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension, Orthostatic Hypotension, Cardiovascular Diseases +2 more
Related terms Cardiovascular Diseases, Central Nervous System Diseases, Hypotension, Hypotension, Orthostatic, Nervous System Diseases, Spinal Cord Diseases, Spinal Cord Injuries, Trauma, Nervous System
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov