Study Summary
This trial will test if repeatedly breathing low oxygen levels for brief periods can help people with chronic spinal cord injuries to recover some motor function.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)
Day 5
Change in muscle strength
Change in overground walking endurance
Change in overground walking speed
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
AIH/Strength
1 of 2
AIH/Walk
1 of 2
Active Control
44 Total Participants · 2 Treatment Groups
Primary Treatment: AIH/Strength · No Placebo Group · N/A
AIH/StrengthActiveComparator Group · 2 Interventions: AIH, Strength · Intervention Types: Other, Other
AIH/WalkActiveComparator Group · 2 Interventions: AIH, Walk · Intervention Types: Other, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,250,094 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
125 Previous Clinical Trials
10,502 Total Patients Enrolled
Foundation Wings For LifeOTHER
13 Previous Clinical Trials
1,160 Total Patients Enrolled
Randy D Trumbower, PT, PhDPrincipal InvestigatorHarvard Medical School (HMS and HSDM)
5 Previous Clinical Trials
168 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The cause of the lesion is non-progressive.
You have a motor-incomplete lesion.
References
- Hoffman, M. S., F. J. Golder, S. Mahamed, and G. S. Mitchell. 2010. “Spinal Adenosine A2areceptor Inhibition Enhances Phrenic Long Term Facilitation Following Acute Intermittent Hypoxia”. The Journal of Physiology. Wiley. doi:10.1113/jphysiol.2009.180075.
- Trumbower, Randy D., Arun Jayaraman, Gordon S. Mitchell, and William Z. Rymer. 2011. “Exposure to Acute Intermittent Hypoxia Augments Somatic Motor Function in Humans with Incomplete Spinal Cord Injury”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968311412055.
- Hayes, Heather B., Stacie A. Chvatal, Margaret A. French, Lena H. Ting, and Randy D. Trumbower. 2014. “Neuromuscular Constraints on Muscle Coordination During Overground Walking in Persons with Chronic Incomplete Spinal Cord Injury”. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2014.02.001.
- Hayes, H. B., A. Jayaraman, M. Herrmann, G. S. Mitchell, W. Z. Rymer, and R. D. Trumbower. 2013. “Daily Intermittent Hypoxia Enhances Walking After Chronic Spinal Cord Injury: A Randomized Trial”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000437416.34298.43.
- Baker-Herman, Tracy L, David D Fuller, Ryan W Bavis, Andrea G Zabka, Francis J Golder, Nicholas J Doperalski, Rebecca A Johnson, Jyoti J Watters, and Gordon S Mitchell. 2003. “BDNF Is Necessary and Sufficient for Spinal Respiratory Plasticity Following Intermittent Hypoxia”. Nature Neuroscience. Springer Science and Business Media LLC. doi:10.1038/nn1166.
- Baker-Herman TL, Fuller DD, Bavis RW, Zabka AG, Golder FJ, Doperalski NJ, Johnson RA, Watters JJ, Mitchell GS. BDNF is necessary and sufficient for spinal respiratory plasticity following intermittent hypoxia. Nat Neurosci. 2004 Jan;7(1):48-55. doi: 10.1038/nn1166. Epub 2003 Dec 14.
- Randy Trumbower, PT, PhD 2014. "Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02323945.
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Conditions
Cancer Related
Treatments