BioFLO for Respiratory Recovery in SCI

Spinal Cord Injuries Clinical Trial

Official title:

Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011876
• Other study ID #: IRB202202891
• Secondary ID: W81XWH2210478
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: September 2027

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Emily J Fox, PT, MHS, PhD
• Phone: 904-742-2500
• Email: ejfox[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• Acute Intermittent Hypoxia (AIH)
AIH (acute intermittent hypoxia) consists of short episodes of low oxygen (9% O2).
• Acute Intermittent Hypercapnic-Hypoxia (AIHH)
AIHH consists of short episodes of low oxygen (9% O2) and elevated carbon dioxide (4% CO2).
• Sham AIH
A single session of sham AIH with episodes of normal room air (21% O2).

Locations

Country	Name	City	State
United States	Brooks Rehabilitation	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	U.S. Army Medical Research Acquisition Activity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, and 45-60 minutes after intervention on AIH day, AIHH day, and Sham AIH day
Primary	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.	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.)
Primary	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.	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.)