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NCT05457205 · ClinicalTrials.gov registry record · NA
Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury
A NA study of Spinal Cord Injuries and Spasticity, Muscle, sponsored by University of Mississippi Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05457205: Recruiting NA study of Spinal Cord Injuries and Spasticity, Muscle, sponsored by University of Mississippi Medical Center.
NCT05457205 is a NA study of Spinal Cord Injuries and Spasticity, Muscle that is actively recruiting participants, run by University of Mississippi Medical Center. The registered enrollment target is 12 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457205, a NA study of Spinal Cord Injuries and Spasticity, Muscle, is actively recruiting participants, sponsored by University of Mississippi Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Spasticity is often disabling because it interferes with hygiene, transfers, and locomotion and can disturb sleep and cause pain. For these reasons, most individuals seek treatments for spasticity after SCI. New developments in electrical neuromodulation with transcutaneous spinal stimulation (TSS) show promising results in managing spasticity non-pharmacologically. The underlying principle of TSS interventions is that the afferent input generated by posterior root stimulation modifies the excitability of the lumbosacral network to suppress pathophysiologic spinal motor output contributing to distinctive features of spasticity. However, the previous TSS studies used almost identical protocols in terms of stimulation frequency and intensity despite the great flexibility offered by this treatment strategy and the favorable results with the epidural stimulation at higher frequencies. Therefore, the proposed study takes a new direction to systematically investigate the standalone and comparative efficacy of four TSS interventions, including those used in previous studies. Our central hypothesis is that electrical neuromodulation with the selected TSS protocols (frequency: 50/100 Hz; intensity: 0.45 or 0.9 times the sub-motor threshold) can reduce and distinctly modify tonic and phasic components of spasticity on short- and long-term basis. We will test our hypothesis using a prospective, experimental, cross-over, assessor-masked study design in 12 individuals with chronic SCI (more than 1-year post-injury). Aim 1. Determine the time course of changes and immediate after-effects of each TSS protocol on tonic and phasic spasticity. The results will reveal the evolution of changes in spa
Conditions Studied
Interventions
- OTHER Electrical neuromodulation
Study Locations (2)
Mississippi
- Methodist Rehabilitation Center - Jackson
- University of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2025-04-05 |
| Phase | NA |
What NCT05457205 shows while recruiting
NCT05457205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Electrical neuromodulation is the first listed.
NCT05457205 reports a single indexed study location in Mississippi.
Frequently Asked Questions
What is clinical trial NCT05457205 about?
NCT05457205 is a clinical study titled "Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury". Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Spasticity ...
What is the current status of trial NCT05457205?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2022-08-16. Estimated completion is 2025-04-05.
What conditions does trial NCT05457205 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Spasticity, Muscle.
What interventions are being tested in trial NCT05457205?
The interventions under investigation include: Electrical neuromodulation (OTHER).
Who is sponsoring clinical trial NCT05457205?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05457205 being conducted?
This trial has 2 study locations across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05457205's enrollment target sits among peer trials
12 165th of 202 higher than 30 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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