Recruiting

Epidural Stimulation

Sponsor:

University of Louisville

Code:

NCT05178056

Conditions

Spinal Cord Injuries

Spinal Cord Stimulation

Breathing Exercises

Rehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Epidural Stimulation

Respiratory Training

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Spinal Cord Stimulation

Breathing Exercises

Rehabilitation

Study ID

NCT05178056

Start date

Dec 31, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years old
  • Stable medical condition
  • Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
  • Sustained SCI at least 24 months prior to entering the study
  • At least 15%-deficit in pulmonary function outcomes

Exclusion Criteria:

  • Painful musculo-skeletal dysfunction
  • Unhealed fracture
  • Contracture
  • Pressure sore
  • Urinary tract infection that might interfere with respiratory training
  • Clinically significant depression
  • Psychiatric disorders
  • Ongoing drug abuse;
  • Major cardiovascular disease
  • Major pulmonary disease
  • Ventilator dependence
  • Major endocrine disorders
  • Malignancy
  • Marked obesity
  • Deep vein thrombosis
  • HIV/AIDS related illness
  • Secondary causes of respiratory dysfunction
  • Major gastrointestinal problems
  • Other major medical illness contraindicated for respiratory training
  • Pregnantcy

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Respiratory Training

Research subjects with no implanted stimulator undergoing RT intervention.

active comparator: Spinal Cord Stimulation

Research subjects with implanted stimulator undergoing stimulation intervention.

experimental: Spinal Cord Stimulation and Respiratory Training

Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.

Interventions

Spinal Cord Epidural Stimulation

Spinal Cord Epidural Stimulation (scES) will be administered by a multi-electrode array (5-6-5 SpecifyTM electrode, MEDTRONIC, Minneapolis, MN, USA) previously implanted in the epidural space over the dorsum of the spinal cord.

Respiratory Training

Standard threshold Positive Expiratory Pressure Device and standard threshold Inspiratory Muscle Trainer (Respironics Inc., Cedar Grove, NJ) assembled together will be used for respiratory training sessions to complete eighty 45-minute sessions during 16 weeks. The participants will be instructed to perform inspiratory and expiratory efforts against a pressure treshold load.

Primary outcome measure

  • Change in Maximum Expiratory Pressure (PEmax) [ Time Frame: Through study completion, an average of 1 year. ]
  • Change in Surface electromyography (sEMG) Magnitude (Mag) [ Time Frame: Through study completion, an average of 1 year. ]
  • Change in Surface electromyography (sEMG) Similarity Index (SI) [ Time Frame: Through study completion, an average of 1 year. ]
  • Change in Maximum Inspiratory Pressure (PImax) [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

Frazier Rehabilitation and Neuroscience Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Alexander V Ovechkin, MD, PhD

More Information

Sponsor

University of Louisville

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Epidural Spinal Cord Stimulation
  • Respiratory Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-03-13.