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NCT05305118

TSCS for Acute SCI

Recruiting now NA Last updated 16 April 2025
What this trial tests

NA trial testing TSCS Mapping in Acute Spinal Cord Injury in 50 participants. Currently enrolling.

Timeline
1 January 2022
Primary endpoint
31 August 2027
1 October 2027

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 January 2022
Primary completion31 August 2027
Estimated completion1 October 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 89, any sex, with Acute Spinal Cord Injury or Blood Pressure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Acute Spinal Cord Injury

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

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Data sources for this page

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