Spinal Cord Stimulation and Respiration After Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Painful musculo-skeletal dysfunction

Unhealed fracture

Contracture

Pressure sore

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Respiratory Training

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Respiratory TrainingActive comparator 1 intervention
Group B: Spinal Cord StimulationActive comparator 1 intervention
Group C: Spinal Cord Stimulation and Respiratory TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Maximum Expiratory Pressure (PEmax)

Standard Spirometry measurement.

Time frame
Through study completion, an average of 1 year.
2

Change in Surface electromyography (sEMG) Magnitude (Mag)

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

Time frame
Through study completion, an average of 1 year.
3

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

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

Time frame
Through study completion, an average of 1 year.
4

Change in Maximum Inspiratory Pressure (PImax)

Standard Spirometry measurement.

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

Change in Forced Vital Capacity (FVC)

Standard Spirometry measurement.

Time frame
Through study completion, an average of 1 year.
2

Change in Forced Expiratory Volume in 1 second (FEV1)

Standard Spirometry measurement.

Time frame
Through study completion, an average of 1 year.
3

Change in Baroreflex sensitivity (BRS)

Measure of the beat-to-beat blood pressure and heart rate variability assessed during a Valsalva maneuver and maximum respiratory effort.

Time frame
Through study completion, an average of 1 year.
4

Change in Baroreflex Effectiveness Index (BEI)

Measure of the beat-to-beat blood pressure and heart rate variability assessed during a Valsalva maneuver and maximum respiratory effort.

Time frame
Through study completion, an average of 1 year.

Other outcomes

1

Changes in Spinal Cord Independence Measure (SCIM) scores

The SCIM (version III) measures the levels of self-care and mobility.

Time frame
Through study completion, an average of 1 year.
2

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

The CHART measure the level of handicap in a community setting: physical independence, mobility, occupation, social integration, economic self-sufficiency.

Time frame
Through study completion, an average of 1 year.

Sponsors and contacts

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University of Louisville

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator