Spinal Cord Stimulation and Respiration After Injury

NCT05178056 | Recruiting DMC FDA Device

• 2 other identifiers: 21.0564/17.1024R01HL150581
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Rehabilitation; Spinal Cord Stimulation; Breathing Exercises

Keywords

Epidural Spinal Cord Stimulation; Respiratory Training

Outcome Measures

Primary Outcomes (4)

• Change in Maximum Expiratory Pressure (PEmax)

  Standard Spirometry measurement.

  Through study completion, an average of 1 year.

• Change in Surface electromyography (sEMG) Magnitude (Mag)

  Respiratory multi-muscle activation measures assessed using standard surface electromyography.

  Through study completion, an average of 1 year.

• Change in Surface electromyography (sEMG) Similarity Index (SI)

  Respiratory multi-muscle activation measures assessed using standard surface electromyography.

  Through study completion, an average of 1 year.

• Change in Maximum Inspiratory Pressure (PImax)

  Standard Spirometry measurement.

  Through study completion, an average of 1 year.

Secondary Outcomes (4)

• Change in Forced Vital Capacity (FVC)

  Through study completion, an average of 1 year.

• Change in Forced Expiratory Volume in 1 second (FEV1)

  Through study completion, an average of 1 year.

• Change in Baroreflex sensitivity (BRS)

  Through study completion, an average of 1 year.

• Change in Baroreflex Effectiveness Index (BEI)

  Through study completion, an average of 1 year.

Other Outcomes (2)

• Changes in Spinal Cord Independence Measure (SCIM) scores

  Through study completion, an average of 1 year.

• Changes in The Craig Handicap Assessment & Reporting Technique (CHART) scores

  Through study completion, an average of 1 year.

Study Arms (3)

Respiratory Training

ACTIVE COMPARATOR

Research subjects with no implanted stimulator undergoing RT intervention.

Other: Respiratory Training

Spinal Cord Stimulation

ACTIVE COMPARATOR

Research subjects with implanted stimulator undergoing stimulation intervention.

Device: Spinal Cord Epidural Stimulation

Spinal Cord Stimulation and Respiratory Training

EXPERIMENTAL

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

Device: Spinal Cord Epidural Stimulation; Other: Respiratory Training

Interventions

Spinal Cord Epidural Stimulation DEVICE

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.

Spinal Cord Stimulation; Spinal Cord Stimulation and Respiratory Training

Respiratory Training OTHER

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.

Respiratory Training; Spinal Cord Stimulation and Respiratory Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Alexander Ovechkin, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Ovechkin, MD, PhD

CONTACT

5025818675; avovec02@louisville.edu

Andrea Willhite, MS

CONTACT

5025818675; andrea.willhite@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Our goal is to evaluate the effects of the individually optimized spinal cord Epidural Stimulation (scES) (Aim 1) and to define the efficacy of scES combined with Respiratory Training (RT) (Aim 2) in individuals with Spinal Cord Injury (SCI). Thirty participants with SCI will be recruited, twenty of them will have scES implanted. After screening and recruitment, primary and secondary outcome measurements will be obtained in the Lab at the following time points: 1) Pre intervention, after 30-days without any stimulation and/or intervention, 2) Post mapping, (participants with scES, n=20), 3) Post Session #40 (after 8 weeks of intervention) and 4) Post Session #80 (after 16 weeks of intervention), and 5) Post 16-weeks Follow-up Period. In total, it is anticipated that 5 measurements will be obtained for each participant with implanted scES and 4 measurements for participants without scES.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: December 31, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)