Even though diaphragm pacing device is offered to aid people with motor neurone disease (MND), a UK study has shown that it doesn't benefit the patients.
A team of MND specialists, led by researchers from the Sheffield Institute of Translational Neuroscience (SITraN), conducted the first randomised controlled multi-centre clinical trial to assess the risks and benefits of the intervention for patients.
The diaphragm pacing device was approved for humanitarian use in MND patients in 2011 by the US Food and Drug Administration, and despite a lack of conclusive evidence for the benefits of the intervention, diaphragm pacing has been widely offered to patients with MND around the world.
The device, which is similar to a heart pacemaker, sends electrical impulses to stimulate the main breathing muscles in the diaphragm.
The results of the Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS) study show that diaphragm pacing was not beneficial when used in addition to non-invasive ventilation (NIV) where slightly pressurised air is delivered into the lungs through a face mask. In fact, patients who used diaphragm pacing lived on average 11 months less than those who used NIV alone.
Lead researcher, Dr Christopher McDermott at the University of Sheffield called the results "incredibly disappointing," and said that unfortunately, DiPALS did not show any benefits for diaphragm pacing in MND and, in fact, their study showed that it may actually be harmful.
The result from DiPALS demonstrates that the increasing 'nothing to lose' approach was inappropriate and standards should not be lowered by starting treatments without clear evidence of benefit, he concluded.
The results are published in the journal Lancet Neurology.