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.
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 now has multi-centre ethical approval and is aiming to recruit participants from October 2011
Project Staff
| Name | Site | Telephone Number | |
|---|---|---|---|
|
Dr Christopher McDermott |
Sheffield Institute for Translational Neuroscience (SITraN) | +44 (0)114 2222261 | c.j.mcdermott@sheffield.ac.uk |
|
Dr Cindy Cooper |
ScHARR | +44 (0)114 2220743 | c.l.cooper@sheffield.ac.uk |
|
Chin Maguire |
ScHARR | +44 (0)114 2220717 | c.maguire@sheffield.ac.uk |
|
John Martindale |
ScHARR | +44 (0)114 2220685 | j.martindale@sheffield.ac.uk |
|
Mike Bradburn |
ScHARR | +44 (0)114 2220706 | m.bradburn@sheffield.ac.uk |
|
Simon Dixon |
ScHARR | +44 (0)114 2220724 | s.dixon@sheffield.ac.uk |
|
Kylie Cross |
ScHARR | +44 (0)114 2226385 | |
| Wendy Baird Qualitative Methodology |
ScHARR | +44 (0)114 2220819 |
Sites
| Site Study Members | Hospital | Role |
|---|---|---|
| Sheffield | ||
| Christopher McDermott | Royal Hallamshire Hospital |
Chief Investigator / |
| Pamela Shaw | Royal Hallamshire Hospital | Principal Investigator |
| Stephen Bianchi | Royal Hallamshire Hospital | Respiratory Consultant |
| Royal Akeroyd | Northern General Hospital | Surgeon |
| Research Nurse | ||
| Manchester | ||
| Andrew Bentley | University Hospital of South Manchester | Principal Investigator/ Respiratory Consultant |
| John Ealing | Salford Royal Hospital Foundation Trust | Consultant Neurologist |
| Simon Galloway | University Hospital of South Manchester | Surgeon |
| Fiona Jefferies | University Hospital of South Manchester | Research Nurse |
| Oxford | ||
| Kevin Talbot | John Radcliffe Hospital | Principal Investigator / Consultant Neurologist |
| John Stradling | John Radcliffe Hospital | Respiratory Consultant |
| Nick Maynard | John Radcliffe Hospital | Surgeon |
| Rachel Marsden | John Radcliffe Hospital | Research Nurse |
| Newcastle | ||
| Tim Williams | Royal Victoria Infirmary | Principal Investigator / Consultant Neurologist |
| Simon Baudouin | Royal Victoria Infirmary | Respiratory Consultant |
| Dayalan Karat | Royal Victoria Infirmary | Surgeon |
| Steve Dodds | Royal Victoria Infirmary | Research Nurse |