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NCT04105114 · ClinicalTrials.gov registry record · Early Phase 1

Transformation of Paralysis to Stepping

A Early Phase 1 study of Spinal Cord Injuries, sponsored by University of Louisville.

Active
Registry status
Early Phase 1
Development phase
15
Enrollment target
1
Study location

NCT04105114 is a Early Phase 1 study of Spinal Cord Injuries that is active but no longer recruiting, run by University of Louisville. The registered enrollment target is 15 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04105114, a Early Phase 1 study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by University of Louisville.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.

Conditions Studied

Interventions

  • DRUG Buspirone
  • DEVICE Non-invasive Spinal Cord Stimulation
  • DEVICE Overground stepping
  • DEVICE Gravity Neutral Device
  • DEVICE Body Weight Supported Treadmill Training

Study Locations (1)

Kentucky

  • Frazier Rehabilitation and Neuroscience Institute - Louisville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-09-30
Est. Completion 2027-12-31
Phase Early Phase 1

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT04105114

The ClinicalTrials.gov registry entry for NCT04105114 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 5 interventions - of which Buspirone is the first listed.

NCT04105114 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT04105114 about?

NCT04105114 is a clinical study titled "Transformation of Paralysis to Stepping". The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoa...

What is the current status of trial NCT04105114?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-09-30. Estimated completion is 2027-12-31.

What conditions does trial NCT04105114 study?

This clinical trial studies the following conditions: Spinal Cord Injuries.

What interventions are being tested in trial NCT04105114?

The interventions under investigation include: Buspirone (DRUG), Non-invasive Spinal Cord Stimulation (DEVICE), Overground stepping (DEVICE), Gravity Neutral Device (DEVICE), Body Weight Supported Treadmill Training (DEVICE).

Who is sponsoring clinical trial NCT04105114?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04105114 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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