N = 1

 Alex & Pediatric Diaphragm Pacing

How an unusual child reached an emerging technology—and what the story teaches us about individualized systems

And the timeline would begin before 2009:

2004 — catastrophic cervicomedullary/high-cervical injury plus diffuse traumatic brain injury.

2005 — another Logan County SCI family discovers Kennedy Krieger Institute (KKI)  

Afterward — Beth calls KKI; Jodi Luttrell recognizes respiratory support as a potential barrier to rehabilitation and directs her to Onders’ diaphragm-pacing team.

Following years — ongoing communication with Mary Jo Elmo and the Onders team while pediatric implantation is being pursued.

2007 — Onders and colleagues publish work explicitly discussing the development of protocols that could permit diaphragm pacing in people younger than 18.

Sometime during this period I received a phone call from Mary Jo Elmo that Dr. Onders was ready to implant a child and Alex was at the top of the list!…Woohoo! 

January 2009 — FDA permission; Alex, age 10, becomes the first child implanted with the intramuscular NeuRx DPS.

2009 onward — pediatric experience grows.

2011 — first published pediatric series.

Later — technology evolves, including battery/power options intended to make the system easier to sustain.

2026 — Alex is still using the technology as his primary respiratory support, while CMS creates a new HCPCS pathway for NeuRx replacement accessories.

And alongside that clinical timeline we’d have another:

What the administrative system might see

“Quadriplegia.”

“Ventilator.”

“Respiratory equipment.”

“Battery.”

versus:

What actually happened

A child with an extraordinarily high injury became the first pediatric recipient of an emerging respiratory technology, developed an unusual long-term combination of diaphragm pacing and ventilator assistance, survived major subsequent spinal complications, demonstrated highly atypical autonomic physiology, and over 17 years accumulated an individualized respiratory-support architecture that doesn’t resemble the ordinary category.

And that is why I keep coming back to the question:

What happens when the person being assessed has a history the model has almost never seen?

Alex isn’t theoretically an outlier.

We now have historical evidence that, in at least one major component of his care, he literally began as N=1. 😳