Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial

BMC Neurology, 2012 · DOI: 10.1186/1471-2377-12-74 · Published: August 16, 2012

Simple Explanation

Motor neurone disease (MND) leads to muscle weakness and death, often due to respiratory insufficiency. Non-invasive ventilation (NIV) is a standard treatment, but some patients don't tolerate it or it becomes ineffective. The DiPALS study investigates diaphragm pacing (DP) as a treatment for MND patients with respiratory insufficiency. Patients will be randomised to NIV alone or DP in addition to NIV, and followed for 12 months. The primary goal is to evaluate the effect of DP on survival in MND patients with respiratory muscle weakness over the study duration.

Study Duration

12 months follow-up period

Participants

108 patients with Motor Neurone Disease

Evidence Level

Level 1: Multi-centre prospective randomised controlled interventional trial

Key Findings

1
The primary objective of this trial will be to evaluate the effect of Diaphragm Pacing (DP) on survival over the study duration in patients with MND/ amyotrophic lateral sclerosis (ALS) with respiratory muscle weakness.
2
Secondary objectives include evaluating the effect of DP on quality-adjusted life years (QALYs), patient quality of life, and carer quality of life.
3
The trial will also assess the safety and tolerability of DP, with study endpoints including adverse events and patient withdrawal from treatment.

Research Summary

The DiPALS study is a multi-centre randomised controlled trial designed to evaluate the effectiveness of diaphragm pacing (DP) in addition to non-invasive ventilation (NIV) for patients with motor neurone disease (MND) and respiratory muscle weakness. 108 patients will be recruited across 5 UK sites and randomized to either NIV alone or NIV plus DP. The primary outcome is overall survival, and secondary outcomes include quality of life, cost-effectiveness, and safety. The study will also incorporate a qualitative component to explore the experiences of patients and carers with DP, and data will be collected at multiple time points over a 12-month follow-up period.

Practical Implications

Potential Improvement in Survival

If DP proves effective, it could significantly extend the survival of MND patients with respiratory insufficiency.

Enhanced Quality of Life

Demonstrating improvements in QALYs and overall quality of life could establish DP as a valuable addition to standard care.

Reduction in NIV Dependence

The study aims to determine if DP can reduce the need for or reliance on non-invasive ventilation, offering a less intrusive respiratory support method.

Study Limitations

1
The study is limited to patients with specific respiratory insufficiency criteria and stimulatable diaphragms, potentially limiting generalizability.
2
Exclusion criteria include pre-existing implanted electrical devices and significant decision-making incapacity, which may further restrict the patient population.
3
The relatively short follow-up period of 12 months may not capture the long-term effects of diaphragm pacing on survival and quality of life.

Your Feedback

Was this summary helpful?

Back to Pulmonology