Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
Respiratory complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our original respiratory training method. However, the effectiveness of this intervention is limited due to the disruption of brain-spinal connections and consequently lowered spinal cord activity below the injury level. Our recent studies showed that electrical stimulation of the spinal cord below the level of injury leads to increased ventilation which indicates activation of the spinal cord structures related to respiration. These findings indicate that spinal cord stimulation can be a promising therapeutic additive to the treatment. The goal of this study is to justify the establishment of a new direction in rehabilitation for patients with SCI by using a non-invasive spinal cord stimulation in combination with respiratory training.
Our aims are: 1) to evaluate the effects of such stimulation applied to the injured spinal cord on pulmonary function and respiratory muscle activity, and 2) to evaluate the effectiveness and therapeutic mechanisms of the spinal cord stimulation combined with respiratory training. Thirty-six individuals with chronic SCI will be recruited and assigned to three groups to receive respiratory training or spinal cord stimulation alone or a combination of them. All participants will be tested before and after cycles of experimental procedures with/or without stimulation. Our hypotheses will be confirmed if the respiratory training combined with spinal cord stimulation results in the most enhanced positive effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old;
stable medical condition;
no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation;
no clinically significant depression, psychiatric disorders or ongoing drug abuse;
Disqualifiers
major pulmonary or cardiovascular disease,
ventilator dependence,
endocrine disorders,
malignancy,
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous spinal cord stimulator
DeviceStimulation to the spinal cord will be administered using Neostim/Biostim (Cosyma Inc., Denver CO) device by applying up to five conductive electrodes placed on the skin at the midline over the thoracic levels as cathodes between T1 to T8, and up to four self-adhesive electrodes located symmetrically on the skin over the iliac crests and shoulders as anodes.
Respiratory Training
DeviceStandard threshold Positive Expiratory Pressure Device (PEP, Respironics Inc., Cedar Grove, NJ) and standard threshold Inspiratory Muscle Trainer (IMT, Respironics Inc., Cedar Grove, NJ) assembled together using a T-shaped connector with a flanged mouthpiece (Airlife 001504) will be used for the respiratory training intervention.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Training (RT) groupActive comparator 1 intervention
Group B: Spinal Cord Transcutaneous Stimulation (scTS) groupActive comparator 1 intervention
Group C: Spinal Cord Transcutaneous Stimulation and Respiratory Training (scTS+RT) groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maximum Expiratory Pressure (PEmax).
Standard Spirometry measurement.
Time frame
Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.2
Maximum Inspiratory Pressure (PImax).
Standard Spirometry measurement.
Time frame
Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.3
Surface electromyography (sEMG) Similarity Index (SI)
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Time frame
Within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.Secondary outcomes
1
Forced Vital Capacity (FVC).
Standard Spirometry measurement.
Time frame
Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.2
Forced Expiratory Volume in 1 second (FEV1).
Standard Spirometry measurement.
Time frame
Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.3
Baroreflex blood pressure sensitivity (BRS).
Measure of the beat-to-beat blood pressure variability assessed during a Valsalva maneuver.
Time frame
Within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.4
Baroreflex heart rate sensitivity (BRS).
Measure of the beat-to-beat heart rate variability assessed during a Valsalva maneuver.
Time frame
Within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.Other outcomes
1
The Craig Handicap Assessment & Reporting Technique (CHART) Questionnaire.
Measures the level of handicap in a community setting.
Time frame
Within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Louisville
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov