Injuries, Spinal Cord Clinical Trial
Official title:
Intramuscular Pacing to Enhance Voluntary Diaphragm Activation
NCT number | NCT02556125 |
Other study ID # | IRB201500402 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | August 11, 2020 |
Verified date | August 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Respiratory dysfunction is the leading cause of death in individuals with spinal cord injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and compromises breathing. Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was developed to replace long-term ventilator support, and is now used acutely post C-SCI (<4 months following injury) to promote ventilator weaning. The impact of diaphragm pacing on respiratory function and diaphragm muscle activation has not been formally evaluated. This is an essential step in determining the efficacy of intramuscular diaphragm stimulation and its effects on respiratory function after SCI. Accordingly, this research study will evaluate the effects of intramuscular diaphragm stimulation and test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in adults with cervical SCIs. The investigators will test the hypothesis by evaluating the effects of diaphragm pacing on neuromuscular activation of the diaphragm by directly recording electromyogram (EMG) activity from the intramuscular pacing electrodes. Recording from these surgically-implanted electrodes allows direct comparisons of EMG activity across time, minimizing methodological limitations inherent with surface or percutaneous EMG recordings. This approach, in association with respiratory assessments, will be used to investigate the impact of diaphragm pacing in adults with intramuscular diaphragm pacing electrodes following acute, traumatic C-SCIs.
Status | Completed |
Enrollment | 16 |
Est. completion date | August 11, 2020 |
Est. primary completion date | August 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute, traumatic cervical spinal cord injuries (C-SCIs), classified according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) as A-C (complete SCI (A); motor complete SCI (B); motor incomplete with minimal motor function (C)), affecting C1-C6 spinal cord segments - Scheduled to undergo implantation of a diaphragm pacer, or who have recently received (in past 5-days) implantation of intramuscular diaphragm pacing electrodes due to severe respiratory impairments and dependence on mechanical ventilation. Exclusion Criteria: - Progressive neuromuscular diseases such as multiple sclerosis and myasthenia gravis - History of neurologic injuries such as stroke or prior SCI - Chest wall injuries or deformities likely to influence breathing - Pulmonary infection - Pregnancy - Cognitive impairments limiting study participation |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
United States | Brooks Rehabilitation | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Brooks Rehabilitation, The Craig H. Neilsen Foundation |
United States,
DiMarco AF, Onders RP, Kowalski KE, Miller ME, Ferek S, Mortimer JT. Phrenic nerve pacing in a tetraplegic patient via intramuscular diaphragm electrodes. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 1):1604-6. — View Citation
Hirschfeld S, Exner G, Luukkaala T, Baer GA. Mechanical ventilation or phrenic nerve stimulation for treatment of spinal cord injury-induced respiratory insufficiency. Spinal Cord. 2008 Nov;46(11):738-42. doi: 10.1038/sc.2008.43. Epub 2008 May 13. — View Citation
Onders RP, Elmo M, Kaplan C, Katirji B, Schilz R. Extended use of diaphragm pacing in patients with unilateral or bilateral diaphragm dysfunction: a new therapeutic option. Surgery. 2014 Oct;156(4):776-84. doi: 10.1016/j.surg.2014.07.021. — View Citation
Onders RP, Khansarinia S, Weiser T, Chin C, Hungness E, Soper N, Dehoyos A, Cole T, Ducko C. Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: positive implications for ventilator weaning in intensive care units. Surgery. 2010 Oct;148(4):893-7; discussion 897-8. doi: 10.1016/j.surg.2010.07.008. Epub 2010 Aug 24. — View Citation
Posluszny JA Jr, Onders R, Kerwin AJ, Weinstein MS, Stein DM, Knight J, Lottenberg L, Cheatham ML, Khansarinia S, Dayal S, Byers PM, Diebel L. Multicenter review of diaphragm pacing in spinal cord injury: successful not only in weaning from ventilators but also in bridging to independent respiration. J Trauma Acute Care Surg. 2014 Feb;76(2):303-9; discussion 309-10. doi: 10.1097/TA.0000000000000112. — View Citation
Romero FJ, Gambarrutta C, Garcia-Forcada A, Marín MA, Diaz de la Lastra E, Paz F, Fernandez-Dorado MT, Mazaira J. Long-term evaluation of phrenic nerve pacing for respiratory failure due to high cervical spinal cord injury. Spinal Cord. 2012 Dec;50(12):895-8. doi: 10.1038/sc.2012.74. Epub 2012 Jul 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electromyogram (EMG) will be used to assess the neuromuscular activation of the diaphragm | Neuromuscular activation of the diaphragm will be assessed by recording diaphragm EMGs from the surgically-implanted intramuscular stimulating electrodes. This approach will allow for comparisons of EMG recordings across time. EMGs will be recorded during non-stimulated respiration (diaphragm pacer turned off) and simultaneously with assessments of respiratory function. A Friedman's ANOVA will be used to test for differences in the EMG outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Primary | Maximal inspiratory pressure will be used to assess diaphragm strength | Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Primary | Sniff nasal inspiratory pressure may be used to assess diaphragm strength | Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Primary | Maximal expiratory pressure will be used to assess respiratory function | Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Primary | Spirometry and flow volume curves/loops will be used to assess respiratory function at rest | Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Primary | Spirometry and forced flow volume curves/loops will be used to assess respiratory function at maximal effort | Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | |
Secondary | American Spinal Cord Injury (ASIA) Impairment Scale | Standardized clinical assessment of sensation and strength based on levels of the spinal cord to classify the severity of injury. The test is clinician-administered; clinical examination conducted to test whether sensation is 0-absent; 1-impaired or 2-normal. The lower score the worse the paralysis and the higher the score will indicate the lesser of the paralysis. | Change in baseline to months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |
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