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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: Recruiting NA study of Blood Pressure and Hypotension, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A brachial BP cuff (Series 400, GE Healthcare, Milwaukee, WI, USA) a finger BP monitor (Finometer ® MIDI Model-2; Finopres Medical Systems BV, Amsterdam, The Netherlands) will be applied. Brachial BP will be monitored at 1-minute intervals for 10-minutes in the supine and 10-minutes in the seated positions.
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 |
What NCT05305118 shows while recruiting
NCT05305118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 286-participant average among 101 other Blood Pressure trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05305118's enrollment target sits among peer trials
50 57th of 101 higher than 41 of 101 other Blood Pressure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Blood Pressure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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