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New treatment option for Respiratory Distress Syndrome
Official title Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
ClinicalTrials.gov ID: NCT05928052
What this study is testing
- What it's testing
- This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study.
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
- Male or female 18-85 years;
- Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully...
- Able to provide informed consent or available next of kin able to provide informed consent;
- Have intact chest/lung, upper and lower extremity anatomy;
- The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
You likely can't join if
- Phrenic nerve or diaphragm pacer;
- History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
- Compromised skin in back (neck, upper and lower back);
- Pregnancy;
- Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
- BMI greater than or equal to 35;
See the full eligibility criteria
- Male or female 18-85 years;
- Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules...
- Able to provide informed consent or available next of kin able to provide informed consent;
- Have intact chest/lung, upper and lower extremity anatomy;
- The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
- Enrollment of subject within 48 hours of intubation;
- Able to induce evoked response of diaphragm muscle by spinal cord TES.
- Phrenic nerve or diaphragm pacer;
- History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
- Compromised skin in back (neck, upper and lower back);
- Pregnancy;
- Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
- BMI greater than or equal to 35;
- Pharmacological paralysis/neuromuscular blockade\ .
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
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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.