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BioFLO for Respiratory Recovery in SCI

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18-70 years of age

Chronic incomplete SCI ≥ 1 year at or below C1-T12

Incomplete SCI based on residual sensory and 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.

Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acute Intermittent Hypoxia (AIH)

    Other intervention

    AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).

  • Acute Intermittent Hypercapnic-Hypoxia (AIHH)

    Other intervention

    AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).

  • Sham AIH

    Other intervention

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Single-session testing daysExperimental treatment 3 interventions
Group B: Respiratory strength training blocksExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in motor evoked potential

The change in peak-to-peak amplitude of the motor evoked potential of the diaphragm will be tested using transcranial magnetic stimulation.

Time frame
Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
2

Change in maximal inspiratory pressure

Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.

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.)
3

Change in maximal expiratory pressure

Maximal expiratory pressure is a non-invasive measure of the maximal force achieved when breathing out against an occluded airway.

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.)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

U.S. Army Medical Research Acquisition Activity

Collaborator

Source ClinicalTrials.gov
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