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New treatment option for Spinal Cord Injuries
Official title Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
ClinicalTrials.gov ID: NCT04883463
What this study is testing
- What it's testing
- This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach.
- Time commitment: about 21 months
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 75
You may be able to join if
- Male or female 18-75 years
- At least 1 year from initial cervical spinal cord injury
- Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury)
- Motor Complete ASIA Impairment Scale (A, B, or C)
- Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation
You likely can't join if
- History of severe autonomic dysreflexia
- Phrenic nerve or diaphragm pacer
- Phrenic nerve paralysis
- Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System...
- Clinically significant depression or ongoing drug abuse as documented in the medical record
- Received lung surgery within one year prior to study enrollment or has active intrinsic lung disease (e.g. COPD, acute or chronic lung infection...
See the full eligibility criteria
- Male or female 18-75 years
- At least 1 year from initial cervical spinal cord injury
- Non-progressive Spinal Cord Injury (SCI) at C2 - C7 (non-conus injury)
- Motor Complete ASIA Impairment Scale (A, B, or C)
- Severe respiratory function compromise requiring dependency on invasive or noninvasive ventilation
- Able to attend weekly testing sessions for up to 21 months.
- Have intact chest/lung, upper and lower extremity anatomy. The neuromuscular connections between the spinal cord and its effector muscles (respiratory and extremity) are required to be intact
- Have intact cognitive ability, able to follow commands/voice concerns, and give consent
- History of severe autonomic dysreflexia
- Phrenic nerve or diaphragm pacer
- Phrenic nerve paralysis
- Musculoskeletal dysfunction, unhealed fracture, pressure ulcer of grade 3 and above in the European Pressure Ulcer Advisory Panel Grading System, active infection
- Clinically significant depression or ongoing drug abuse as documented in the medical record
- Received lung surgery within one year prior to study enrollment or has active intrinsic lung disease (e.g. COPD, acute or chronic lung infection, moderate to severe asthma, emphysema, cystic fibrosis, etc.)
- Cardiopulmonary disease that precludes training or rehabilitation
- Other implanted stimulation devices
- Pregnant
- Severe cardiac disease (e.g. heart failure, atherosclerosis, arrhythmia, stroke, etc.)
- people involved in other clinical trials not associated with this trial
- Botox injections in respiratory associated muscles within the last 3 months
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 study runs about 21 months 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 to 75 years. 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.
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.