Spinal Cord Stimulation and Respiration After Injury

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT05178056
Status
Recruiting
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Conditions

  • Breathing Exercises
  • Rehabilitation
  • Spinal Cord Injuries
  • Spinal Cord Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2021
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Change in Maximum Expiratory Pressure (PEmax) [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Frazier Rehabilitation and Neuroscience InstituteLouisvilleKentucky40202
Adrea Willhite, MS
[email protected]
502-582-8675
Alexander V Ovechkin, MD, PhD (PRINCIPAL_INVESTIGATOR)
Susan J Harkema, PhD (SUB_INVESTIGATOR)

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By research site
Frazier Rehabilitation and Neuroscience Institute· Louisville, KY

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