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BioFLO for Respiratory Recovery in SCI

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ClinicalTrials.gov Identifier: NCT06011876
Recruitment Status : Recruiting
First Posted : August 25, 2023
Last Update Posted : January 3, 2024
Sponsor:
Collaborator:
U.S. Army Medical Research Acquisition Activity
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (~15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Acute Intermittent Hypoxia (AIH) Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH) Other: Sham AIH Not Applicable

Detailed Description:

This study will consist of two parts - single-session testing days, and respiratory strength training blocks. If a participant is not eligible to enroll in single-day testing, they will be asked to enroll in only the respiratory strength training blocks.

On single-session testing days, participants will be asked to come in on three separate days they will complete a battery of tests, then be given one of three interventions, and then complete the same battery of tests. The three interventions are acute intermittent hypoxia (AIH), acute intermittent hypercapnic-hypoxia (AIHH), or sham acute intermittent hypoxia (sham AIH). These interventions are explained in more detail below.

During respiratory strength training blocks, participants will receive five days of AIH, AIHH, or sham AIH in combination with respiratory strength training, which uses small hand-held devices to strengthen the muscles used for breathing. Participants will be asked to complete all three blocks to receive all three interventions. In addition to 5 days of interventions and respiratory strength training, the respiratory strength training blocks include testing 1 day, 3 days, and 7 days after the 5 days of respiratory strength training.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI
Actual Study Start Date : December 21, 2023
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-session testing days
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.
 Other: Acute Intermittent Hypoxia (AIH)
AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).

Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH)
AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).

Other: Sham AIH
A single session of sham AIH with episodes of normal room air (21% O2).
Experimental: Respiratory strength training blocks
Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.
 Other: Acute Intermittent Hypoxia (AIH)
AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).

Other: Acute Intermittent Hypercapnic-Hypoxia (AIHH)
AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).

Other: Sham AIH
A single session of sham AIH with episodes of normal room air (21% O2).


Outcome Measures
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Primary Outcome Measures :
  1. Change in motor evoked potential [ Time Frame: Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day ]
    The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation.

  2. Change in maximal inspiratory pressure [ Time Frame: Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.) ]
    Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.

  3. Change in maximal expiratory pressure [ Time Frame: Baseline, 1 day, 3 days, and 7 days after intervention blocks (daily AIH + respiratory strength training, daily AIHH + respiratory strength training, daily sham AIH + respiratory strength training.) ]
    Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18-70 years of age
  • Chronic SCI for > 1 year, at or below C-3 to T-12
  • Incomplete SCI based on residual sensory or motor function below the level of the injury, or injury classification of B, C, D at initial screening, according to the American Spinal Injury Association Impairment Classification, and the International Standards for the Neurological Classification of SCI
  • Medically stable with physician clearance
  • SCI due to non-progressive etiology
  • 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values

Exclusion Criteria:

  • Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
  • Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension
  • Severe neuropathic pain
  • Known pregnancy
  • Severe recurrent autonomic dysreflexia

Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT06011876


Contacts
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Contact: Emily J Fox, PT, MHS, PhD 904-742-2500 ejfox@phhp.ufl.edu
Contact: Hannah Snyder, M.S. 904-345-6910 Hannah.snyder@brooksrehab.org

Locations
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United States, Florida
Brooks Rehabilitation Recruiting
Jacksonville, Florida, United States, 32216
Contact: Emily J. Fox, MHS, DPT, PhD    (904) 742-2500    ejfox@phhp.ufl.edu   
Sponsors and Collaborators
University of Florida
U.S. Army Medical Research Acquisition Activity
Investigators
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Principal Investigator: Emily Fox, DPT, MHS, PhD University of Florida & Brooks Rehabilitation
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT06011876    
Other Study ID Numbers: IRB202202891
W81XWH2210478 ( Other Grant/Funding Number: US ARMY MED RES ACQUISITION )
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
acute intermittent hypoxia
spinal cord injury
breathing
motor function
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries