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New treatment option for Spinal Cord Injuries
Official title BioFLO for Respiratory Recovery in SCI
ClinicalTrials.gov ID: NCT06011876
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Medically stable with physician clearance
You likely can't join if
- 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...
- Severe neuropathic pain
- Known pregnancy
- Severe recurrent autonomic dysreflexia Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac...
See the full eligibility criteria
- 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...
- 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...
- Medically stable with physician clearance
- SCI due to non-progressive etiology
- 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.