A randomised controlled trial in patients with respiratory muscle weakness due to motor neurone disease of the NeuRx RA/4 Diaphragm Pacing System
|Sponsor||Royal Free London NHS Foundation Trust|
|Funder||NIHR Health Technology Assessment Programme / Motor Neurone Disease Association / Department of Health subvention funding|
|CI||Dr Richard Orrell|
|UK sites||London Queen square|
Non Invasive Ventilation (NIV) therapy is the current
standard treatment to help patients with MND to breathe. Patients wear a face
mask over their nose or mouth or both and as they breathe in, the machine gives
an extra push of air to support the patient's weak breathing muscles, enabling
a bigger deeper breath.
Some MND patients do not tolerate NIV due to the type
of mask they have. Day time problems with using NIV include claustrophobia,
feeding and communication.
Eventually respiratory muscle weakness will reach a
point where intermittent/overnight NIV is ineffective.
Diaphragm pacing (DP) is a mean of increasing the strength of the main breathing muscle. The NeuRx RA/4 Diaphragm Pacing System has been developed for patients unable to control their diaphragms because of MND.
The pacing wires are inserted into the diaphragm muscle during a small operation and are connected to a small portable box.
Primary objective: to assess if treatment with DP combined with standard care with NIV prolongs life and maintains quality of life
108 patients were recruited in up to 10 NHS hospitals in the
Patients were randomised to either have NIV or receive DP plus NIV.
Patients had to complete outcome measures at 5 follow up time points (2, 3, 6,
9 and 12 months).
Patients in the DP group had extra visits for surgery and a 1
week post-operative follow up.
12 patients (and their carers) from the DP group were also asked to complete 2 qualitative interviews.