The DiPALS study is a randomised controlled trial evaluating NeuRx/4 Diaphragm Pacing
in patients with respiratory muscle weakness due to Motor NeuroneDisease.
Motor neurone disease (MND) is a devastating illness which leads to muscle weakness and breathing difficulties. Non Invasive Ventilation (NIV) therapy is the current standard treatment to help allow these patients to breathe. Patients wear a face mask over their nose or mouth or both. 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 however do not tolerate NIV due to the type of mask they have. During the day problems with using NIV include mask interface problems, claustrophobia, feeding and communication. Eventually respiratory muscle weakness will progress to a point at which intermittent/overnight NIV is ineffective.
Diaphragm pacing (DP) is a means of increasing the strength of the main breathing muscle.
The NeuRx RA/4 Diaphragm Pacing System has been developed for patients who are unable to control their diaphragms because of stable high spinal cord injuries or because they have a neuromuscular disease such as MND. The pacing wires are inserted into the diaphragm muscle during a small operation and are connected to a small portable box that the patient can easily carry about.
The proposed study will assess if treatment with DP prolongs life and maintains quality of life when given in addition to current standard care with NIV.
108 patients will be recruited to the study in up to 10 NHS sites in the UK. Patients will be randomised to either have NIV or receive DP in addition to NIV. Study participants will be required to complete outcome measures at 5 follow up time points (2, 3, 6, 9 and 12 months). Patients in the DP group will have additional visits for surgery and a 1 week post-operative follow up. 12 patients (and their carers) from the DP group will also be asked to complete 2 qualitative interviews. The project is funded by the HTA (Health Technology Assessment) Programme and the Motor Neurone Disease Association.
The study is currently in patient follow-up.
The project is funded by the NIHR HTA (Health Technology Assessment) Programme and the Motor Neurone Disease Association.
For more information please visit the UK Clinical Research Network Portfolio:
Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial. McDermott CJ, Maguire C, Cooper CL, Ackroyd R, Baird WO, Baudouin S, Bentley A, Bianchi S, Bourke S, Bradburn MJ, Dixon S, Ealing J, Galloway S, Karat D, Maynard N, Morrison K, Mustfa N, Stradling J, Talbot K, Williams T, Shaw PJ. BMC Neurol. 2012 Aug 16;12:74. doi: 10.1186/1471-2377-12-74
Prof Christopher McDermott
Professor in Neurology and Honorary Consultant based in SITraN.
Mrs Chin Maguire
University of Sheffield
Health Services Research, School of Health & related Research (ScHARR)
30 Regent Street
Tel: 0114 2220717