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New treatment option for Spinal Cord Injuries
Official title Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
ClinicalTrials.gov ID: NCT06019949
What this study is testing
- What it's testing
- Respiratory complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our original respiratory training method.
- Time commitment: about 16 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years old;
- stable medical condition;
- no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with...
- no clinically significant depression, psychiatric disorders or ongoing drug abuse;
- non-progressive SCI (no negative change in the neurological level and motor-completeness assessed during screening when compared to the neurological...
You likely can't join if
- Participants will be excluded from the study if there is a presence of
- major pulmonary or cardiovascular disease,
- ventilator dependence,
- endocrine disorders,
- malignancy,
- marked obesity,
See the full eligibility criteria
- At least 18 years old;
- stable medical condition;
- no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation;
- no clinically significant depression, psychiatric disorders or ongoing drug abuse;
- non-progressive SCI (no negative change in the neurological level and motor-completeness assessed during screening when compared to the neurological status assessed at 6-mo period after injury or at least 6 months prior...
- sustained SCI at least 12 months prior to entering the study;
- compared to the normative values for healthy population, at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) as detected by screening spirometry.
- Participants will be excluded from the study if there is a presence of
- major pulmonary or cardiovascular disease,
- ventilator dependence,
- endocrine disorders,
- malignancy,
- marked obesity,
- deep vein thrombosis,
- HIV/AIDS-related illness,
- secondary hypotension (anemia, hypervolemia, endocrine and neurological diseases),
- major esophageal/gastrointestinal problem or other major medical illness contraindicated for respiratory training or testing. During screening, the potential participant will be asked whether she is pregnant or planning...
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, 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 study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, 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.