NCT00010374

Who might be able to join this trial:

• You must be 18 years old or older
• You must have a spinal cord injury in the neck area and depend on a machine to help you breathe
• Your condition must be medically stable after the spinal cord injury
• The nerves that control your breathing (phrenic nerves) on both sides of your body must be working at an acceptable level, confirmed by nerve and muscle tests
• Your diaphragm (the main breathing muscle) must show movement when stimulated, as seen on an X-ray imaging test
• Your blood oxygen levels must be at an acceptable level when breathing normal room air (above 90%)
• Your heart and blood pressure must be stable
• You must not have any other health conditions that would prevent the device from being placed or working properly
• You must have a dedicated primary caregiver who is committed to supporting you
• If you are a woman who could become pregnant, you must have a negative pregnancy test
• You (or your legal representative) must agree to take part by signing a consent form

Who may not be able to join:

• You have health conditions that make surgery too risky
• You have an active lung disease, such as asthma, or other breathing-related conditions
• You have an active heart or blood vessel disease
• You have an active brain condition or disease
• Your blood pressure is unstable or your oxygen levels are too low when breathing normal room air
• You were hospitalised for an infection or were treated for an active infection in the last 3 months
• You have a significant curvature of the spine or a chest shape that could cause problems (confirm with trial site)
• You are significantly overweight in a way that could affect the procedure (confirm with trial site)
• There are concerns that you or your caregiver may not be able to follow the trial requirements as expected
• You are currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.