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NCT05305118 · ClinicalTrials.gov registry record · NA
TSCS for Acute SCI
A NA study of Blood Pressure and Hypotension, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05305118 is a NA study of Blood Pressure and Hypotension that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 50 participants, below the 286-participant average among 101 other Blood Pressure trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05305118, a NA study of Blood Pressure and Hypotension, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.
Conditions Studied
Interventions
- PROCEDURE TSCS Mapping
- DEVICE Transcutaneous spinal cord stimulation
Study Locations (1)
New York
- Mount Sinai Spinal Cord Injury Model System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2027-10-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05305118
The ClinicalTrials.gov registry entry for NCT05305118 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 286-participant average among 101 other Blood Pressure trials with a reported enrollment target (83% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Blood Pressure appearing as the primary indexed condition, and to 2 interventions - of which TSCS Mapping is the first listed.
NCT05305118 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05305118 about?
NCT05305118 is a clinical study titled "TSCS for Acute SCI". This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with perfor...
What is the current status of trial NCT05305118?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-01-01. Estimated completion is 2027-10-01.
What conditions does trial NCT05305118 study?
This clinical trial studies the following conditions: Blood Pressure, Hypotension, Acute Spinal Cord Injury.
What interventions are being tested in trial NCT05305118?
The interventions under investigation include: TSCS Mapping (PROCEDURE), Transcutaneous spinal cord stimulation (DEVICE).
Who is sponsoring clinical trial NCT05305118?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05305118 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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