Diaphragm Pacer

 Sometimes N=1 Becomes the Beginning of Something Much Bigger

In January 2009, my son Alex became the first child implanted with Dr. Raymond Onders’ intramuscular NeuRx Diaphragm Pacing System.

He was 10 years old.

At that moment, pediatric experience with this particular system was essentially:

N = 1.

Alex.

That distinction matters because diaphragm pacing itself was not new. Earlier systems that stimulated the phrenic nerve had been used in some children for decades.

But Dr. Onders and his team at University Hospitals in Cleveland had developed a different approach: a minimally invasive laparoscopic procedure that places electrodes directly into the diaphragm at carefully mapped motor points.

Before Alex, the NeuRx system had been used in adults, including adults who had sustained spinal cord injuries as children.

The research team had actually published work in 2007 specifically examining those patients as they prepared protocols for eventually implanting children younger than 18.

Then came Alex.

After years of communication with Dr. Onders’ team while they worked toward permission to implant a child, Alex received his system in January 2009.

A contemporary Cleveland publication reported:

“In January 2009, Alex became the youngest patient — the first child — to have the pacing device implanted.”

And then something remarkable happened.

N=1 didn’t stay N=1.

In 2011, Dr. Onders and colleagues published the first reported experience with intramuscular diaphragm pacing in ventilator-dependent children.

There were now six children, ages 5–17.

All six were successfully implanted. Five participated in home-based ventilator-weaning programs. One child implanted only 11 days after spinal cord injury never returned to mechanical ventilation while using diaphragm pacing.

The researchers concluded that diaphragm pacing could successfully replace or substantially reduce mechanical ventilation in these children.

Then the experience kept growing.

January 2009: Alex becomes the first pediatric recipient.

2011: The first published pediatric series reports 6 children.

By May 2012: The University Hospitals team reports 11 pediatric patients, ranging from 27 months to 17 years old.

By September 2018: The team reports 30 pediatric patients, ranging from just 14 weeks to 17 years old.

And the work continued.

At the 2025 American Pediatric Surgical Association meeting, researchers from University Hospitals/Case Western Reserve and Rainbow Babies & Children’s Hospital reported a retrospective pediatric diaphragm-pacing experience through 2023.

Their dataset contained 42 pediatric patients who had undergone diaphragm-pacer placement, including 18 children with traumatic spinal cord injuries.

Among those 18 children with traumatic SCI:

• 10 were able to replace mechanical ventilation with pacing full-time;
• three paced for 12–16 hours per day;
• four eventually regained autonomous breathing;
• three were decannulated; and
• one avoided tracheostomy placement.

The median duration of continuous pacing use in that traumatic-SCI group was more than nine years.

Think about that progression:

1 child → 6 children → 11 children → 30 children → a pediatric clinical experience that continued growing.

And somewhere at the beginning of that line is a 10-year-old boy from rural Ohio.

What I love about this story isn’t simply that Alex was “first.”

It’s what happened after the first.

Someone had to be the first child for physicians to learn from.

Then the knowledge gained from those early children could inform care for the children who came afterward.

That’s how medicine sometimes advances.

Carefully.

With evidence.

With safeguards.

With physicians willing to acknowledge what they know—and what they don’t yet know.

And with an individual who doesn’t fit the existing dataset.

Sometimes the outlier isn’t evidence that something doesn’t work.

Sometimes the outlier is where the next body of evidence begins.

Alex was once N=1.

Today there are children who have benefited from a pediatric diaphragm-pacing program that did not yet exist when we first began asking whether there might be another way for him to breathe.

That’s pretty incredible.

And perhaps there’s a broader lesson in that:

When the model has never seen someone like the person in front of it, don’t force the person to fit what the model already knows.

Study the person.

Understand the physiology.

Build the appropriate safeguards.

Learn.

And allow what you learn from the individual to make the system better for the next person.