Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02274116|
Recruitment Status : Recruiting
First Posted : October 24, 2014
Last Update Posted : June 27, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation over time.
The investigators hypothesize:
- Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI)
- AIH exposure will increase multijoint reflex excitability of leg muscles in persons with incomplete cervical SCI
- AIH exposure will increase walking performance in persons with incomplete cervical SCI
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: SHAM - Intermittent Room Air - room air mixture Other: AIH - Intermittent Hypoxia - hypoxia air mixture||Not Applicable|
Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury. Repetitive exposure to mild hypoxia triggers a cascade of events in the spinal cord, including new protein synthesis and increased sensitivity in the circuitry necessary for breathing and walking. Recently, the investigators demonstrated that daily (5 consecutive days) of intermittent hypoxia stimulated walking enhancement in persons with chronic spinal cord injury.
Despite these exciting findings, important clinical questions remain. For example, the investigators do not know if prolonged, but less intense intermittent hypoxia induces longer-lasting motor recovery as has been shown in rat models. The investigators hypothesize that repetitive exposures to modest bouts of low oxygen will enhance and prolong walking recovery in persons with chronic spinal cord injury. The investigators anticipate intermittent hypoxia-induced improvements in overground walking ability, likely due to greater balance in excitatory and inhibitory neural transmission. Whereas excitatory inputs drive walking, inhibitory inputs sculpt and coordinate muscle activity; yet so often remain compromised after chronic injury. Thus, the investigators also predict that repetitive exposures to intermittent hypoxia will result in improved inhibition and subsequently enhance muscle coordination during walking. The investigators will use multiple experimental approaches, including muscle electromyography, measurements of walking dynamics and stretch reflexes. Finally, it is critical to assure that repetitive exposures to intermittent hypoxia do not elicit pathologies characteristic of more severe, chronic hypoxia experienced by individuals with obstructive sleep apnea. The investigators will confirm that repetitive exposure to mild bouts of intermittent hypoxia is safe.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Repetitive Exposure of Intermittent Hypoxia to Enhance Walking Recovery in Persons With Chronic Spinal Cord Injury|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||August 2023|
Active Comparator: Intermittent Hypoxia (AIH)
Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen.
Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes
Other: AIH - Intermittent Hypoxia - hypoxia air mixture
Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 5 times per week for 2 weeks.
Sham Comparator: Intermittent Room Air (SHAM)
Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air.
Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes
Other: SHAM - Intermittent Room Air - room air mixture
Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 5 times per week for 2 weeks.
- Change in overground walking endurance [ Time Frame: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks ]walking endurance (6 minute walk test - how far one can walk in 6 minutes)
- Change in overground walking speed [ Time Frame: Baseline, immediately following intervention (day 5), and at 1, 2, and 4 weeks ]walking speed (10 meter walk test - how fast one can walk in 10 meters)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 to 75 years old (the latter to reduce likelihood of heart disease);
- medically stable with clearance from physician to participate;
- motor---incomplete SCI at C2---L5 with non---progressive etiology;
- >6 months since SCI to ensure minimal confounds of spontaneous neurological recovery;
- those classified as ambulatory must have the ability to advance one step overground without human assistance.
- concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs;
- less than 24 on the Mini-mental Exam;
- recurrent autonomic dysreflexia
- cardiopulmonary complications
- concurrent physical therapy
- pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274116
|Contact: Randy D Trumbower, PT, PhDemail@example.com|
|Contact: Stella Barth, BAfirstname.lastname@example.org|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Randy D Trumbower, PT, PhD 617-952-6951 email@example.com|
|Contact: Melissa DeChellis (617) 952-6953 firstname.lastname@example.org|
|Principal Investigator:||Randy D Trumbower, PT, PhD||Spaulding Rehabilitation Hospital|
|Responsible Party:||Randy Trumbower, PT, PhD, Assistant Professor, Spaulding Rehabilitation Hospital|
|Other Study ID Numbers:||
|First Posted:||October 24, 2014 Key Record Dates|
|Last Update Posted:||June 27, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
acute intermittent hypoxia
incomplete spinal cord injury
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Respiratory