Welcome to the DiPALS study website
The DiPALS study is a randomised controlled trial evaluating NeuRx/4 Diaphragm Pacing in patients with respiratory muscle weakness due to Motor Neurone Disease.
The study is now complete. To find out more about the results of the study, please use the link below to access our publication in Lancet Neurology:
- Safety and efficacy of diaphragm pacing in patients with respiratory insuffi ciency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial (Lancet Neurology, July 2015)
Also, please use the link below to hear an interview with Dr. Christopher McDermott, where he discusses the results of the DiPALS study:
Overview of Results:
Why was the study done?
Motor neurone disease (MND) is a progressive disorder for which there is no cure. One aspect of MND, which usually occurs later on in the illness, is weakness of the breathing muscles, including the diaphragm (the main breathing muscle). The main cause of death in MND is directly as consequence of the weakened breathing muscles. Non Invasive Ventilation (NIV) therapy is a proven treatment given to patients with MND to help them breathe. Research has shown that NIV is beneficial, extending good quality life by approximately 7 months. NIV however has its problems, and not everyone can easily use the NIV machine. The NeuRx RA/4 diaphragm pacing system (DPS) is a device that stimulates the nerves of the diaphragm muscle causing it to contract directly. 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 Food and Drug Administration (FDA) in the USA approved the system on humanitarian grounds for patients with MND who need help with their breathing based on limited research data. We have conducted further research – the DiPALS study - to provide clearer information on whether DPS might help patients live longer when used together with NIV, compared to patients using NIV alone.
How was the study done?
DiPALS was a study conducted across a number of specialist UK hospitals. Patients who were eligible to be included in the study were either treated with NIV alone or with NIV plus DPS. Patients could enter the trial if they were aged 18 years or older, with a diagnosis of MND; be taking riluzole medication for at least 30 days; and show clinically that they are experiencing breathing problems. The primary result the study was looking at was overall survival i.e. the length of time patients lived from entering into the study. DiPALS is registered at the ISRCTN Registry: ISRCTN53817913.
What are the main findings from the study?
74 participants (37 per arm) joined the study between Dec 5, 2011 and Dec 18, 2013. On December 18 2013, the committee that was in charge of guarding patient safety (the Data Monitoring and Ethics Committee (DMEC)) recommended that researchers stop entering any more patients into the study. They were concerned that some of the data collected was showing early signs that patients may not be doing well if they were in the DPS group. They did not think that the device was showing any signs of harm however and asked that patients who were given the DPS continue to use it as long as originally planned. After looking at the results in June 2014, the same committee advised that patients who were using the DPS stop using it entirely as it may be causing harm to patients. At this point patients in the DPS group had survived on average 11 months from study commencement and patients in the NIV group had survived on average 17 months. Observation of patients continued until the planned end of the study in December 2014. The final results of the study found that patients survived on average 11.1 months in the DPS group and 22.8 months in the NIV group.
What do the study results mean?
Patients receiving DPS had worse survival than patients not using DPS. Based on these results diaphragmatic pacing should not be used as a routine treatment for patients with MND.
How was the study funded?
This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR-HTA) Programme (project number 09/55/33) and the Motor Neurone Disease Association of England, Wales and Northern Ireland.
|Dr Christopher McDermott
|Sheffield Institute for Translational Neuroscience (SITraN)||+44 (0)114 email@example.com|
|Dr Cindy Cooper
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|ScHARR||+44 (0)114 email@example.com|
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Trial Support Officer
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|Site Study Members||Hospital||Role|
|Christopher McDermott||Royal Hallamshire Hospital||Chief Investigator /
|Pamela Shaw||Royal Hallamshire Hospital||Principal Investigator|
|Stephen Bianchi||Royal Hallamshire Hospital||Respiratory Consultant|
|Roger Ackroyd||Northern General Hospital||Surgeon|
|Andrew Bentley||University Hospital of South Manchester||Principal Investigator/
|John Ealing||Salford Royal Hospital Foundation Trust||Consultant Neurologist|
|Simon Galloway||University Hospital of South Manchester||Surgeon|
|Katie McCalman||University Hospital of South Manchester||Research Nurse|
|Kevin Talbot||John Radcliffe Hospital||Principal Investigator /
|John Stradling||John Radcliffe Hospital||Respiratory Consultant|
|Nick Maynard||John Radcliffe Hospital||Surgeon|
|Rachel Marsden||John Radcliffe Hospital||Research Nurse|
|Tim Williams||Royal Victoria Infirmary||Principal Investigator /
|Simon Baudouin||Royal Victoria Infirmary||Respiratory Consultant|
|Dayalan Karat||Royal Victoria Infirmary||Surgeon|
|Steve Dodds||Royal Victoria Infirmary||Research Nurse|
|Philip Hughes||Derriford Hospital||Principal Investigator/
|Oliver Hanemann||Derriford Hospital||Neurology Consultant|
|Richard Berresford||Derriford Hospital||Surgeon|
|Mary Jo Trimmer||Derriford Hospital||Research Nurse|
|Mark Elliott||St James University Hospital||Principal Investigator|
|Agam Jung||St James University Hospital||Consultant Neurologist|
|Abezar Sarela||St James University Hospital||Surgeon|
|Clair Favager||St James University Hospital||Research Nurse|
|Craig Armstrong||St James University Hospital||Research Nurse|
|Richard Orrell||Royal Free Hospital||Principal Investigator|
|Christine Mickelson||Royal Free Hospital||Consultant Respiratory Therapist|
|Zak Rahman||Royal Free Hospital||Surgeon|
|Mark Baker||Royal Free Hospital||Research Nurse|