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New treatment option for Spinal Cord Injuries
Official title Neurostimulation for Respiratory Function After Spinal Cord Injury
ClinicalTrials.gov ID: NCT05756894
What this study is testing
- What it's testing
- The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is: Changes in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals. Participants will complete a maximum of 55 study visits.
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 85
You may be able to join if
- Male and females between ages 18-85 years
- SCI at least 6 months post-injury
- Spinal Cord injury at C1-C5
- Demonstrate respiratory deficit following spinal cord injury as following: (1) Individuals using mechanical ventilation, and (2) individuals with...
- Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.
You likely can't join if
- Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol...
- Any debilitating disease prior to the SCI that caused exercise intolerance.
- Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
- Premorbid, ongoing major depression or psychosis, altered cognitive status.
- History of head injury or stroke
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
See the full eligibility criteria
- Male and females between ages 18-85 years
- SCI at least 6 months post-injury
- Spinal Cord injury at C1-C5
- Demonstrate respiratory deficit following spinal cord injury as following: (1) Individuals using mechanical ventilation, and (2) individuals with pulmonary function testing (PFT) deficits corresponding to having a vital...
- Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.
- Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
- Any debilitating disease prior to the SCI that caused exercise intolerance.
- Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
- Premorbid, ongoing major depression or psychosis, altered cognitive status.
- History of head injury or stroke
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
- History of seizures or epilepsy
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
- Pregnant females
- If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
- Metal plate in skull
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
- Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.