NCT05178056

Spinal Cord Stimulation and Respiration After Injury

Recruiting now NA Last updated 13 March 2026

What this trial tests

NA trial testing Spinal Cord Epidural Stimulation in Spinal Cord Injuries in 30 participants. Currently enrolling.

Timeline

31 December 2021

Primary endpoint
28 February 2027

31 December 2030

Quick facts

Lead sponsor	University of Louisville
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	30
Start date	31 December 2021
Primary completion	28 February 2027
Estimated completion	31 December 2030
Sites	1 location across United States

Drugs / interventions tested

• Spinal Cord Epidural Stimulation
• Respiratory Training

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Spinal Cord Stimulation — all drugs for Spinal Cord Stimulation →
• Breathing Exercises — all drugs for Breathing Exercises →
• Rehabilitation — all drugs for Rehabilitation →

Sponsor

University of Louisville

Who can join

18 and older, any sex, with Spinal Cord Injuries or Spinal Cord Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710