The Non-Pharma Landscape — Big Clinical Players

AFAIK Dispatch #8

Alzheimer’s Families for Action, Innovation and Knowledge

Introduction

I have taken the position in this AFAIK series that pharmacological treatments for Alzheimer’s Disease and other forms of cognitive decline see an overwhelming majority of funding and attention relative to neurostimulation approaches. Looked at from the other direction, the big clinical players in neurostimulation are not focused very much on AD.

I attended the recent Consumer Electronics Show, where Abbott Laboratories was featuring positive results from their neurostimulation-based treatments for Parkinson’s. While this is very positive, it led me to look around their exhibit for any sign of AD treatments. Finding none, I asked an Abbott researcher at the booth about that absence, and he said something to the effect that neurostimulation treatment effects are “difficult to measure and assign results” to the particular treatment. Hmm.

News From NANS 2023

The event I missed was the North American Neuromodulation Society, with a more clinically focused but still tech based agenda. Speakers and exhibitors were focused on brain stimulation trials or products for a number of conditions:

- Movement Disorders

- Epilepsy

- Chronic Pain

- Spinal Cord Injury

• Parkinson’s Disease

Pain was still a major focus — here’s a typical announcement

Saluda Medical held a launch event to celebrate the FDA approval and US launch of their Evoke system. This is a big deal, as Evoke is the first SCS system that continuously monitors spinal cord stimulation therapy and automatically updates treatment parameters to improve the patient experience and therapy efficacy.

No mentions at all about neuromodulation for treating cognitive decline. I’m wondering if epilepsy and Parkinson’s are more characteristically electromagnetic phenomena — and sudden and episodic — whereas AD is slow and accretive. But, “It is widely admitted that Alzheimer’s disease leads to a reduction in the complexity of EEG signals and changes in EEG synchrony,” according to a 2018 article on AD diagnostics. A future dispatch will report on a further review of the literature on brain stimulation for AD — for example, this 2018 study that reported

Given recent challenges in developing new treatments for Alzheimer dementia (AD), it is vital to explore alternate treatment targets, such as neuromodulation for circuit dysfunction. We previously reported an exploratory Phase IIb double-blind trial of deep brain stimulation targeting the fornix (DBS-f) in mild AD (the ADvance trial). We reported safety but no clinical benefits of DBS-f versus the delayed-on (sham) treatment in 42 participants after one year. However, secondary post hoc analyses of the one-year data suggested a possible DBS-f benefit for participants ≥ 65 years.

EEG at NANS

I write this AFAIK series on neurostimulation, but also do work on direct-to-consumer EEG devices and applications, and was just named chair of a Consumer Technology Association working group to set baseline standards for such hardware platforms.

From her NANS report, commentator Hannah Claridge noted:

It was interesting that the first 3 plenary talks were all about brain-computer interfaces, specifically relating to novel technologies (Shadi Dayeh), language recovery (Edward Chang), and restoring movement (Elizabeth Tyler-Kabara, MD, PhD). It was fantastic to see these impressive advances shared and celebrated, but I admit the line-up surprised me, simply because NANS has been very focused on pain and spinal cord stimulation in recent years. Perhaps this will evolve over the coming years?

Hope so.

NANS Exhibitors of Interest

- SENSOMEDICAL — product development company, working on hardware and software products for neurology.

- Curonix — neurostim for pain relief

- ElectroCore — vagus nerve stimulation

- NeuroField Neurotherapy — neurofeedback, neurostimulation, QEEG brain “mapping”

- Osypka Medtec — device manufacturer

- Nevro — neurostimulation for chronic pain.

So, not much there for cognitive treatments, but the ongoing “democratization” of neurotech of all kinds will, I believe, lead to more options for patients and families over time.

Insurance Attacks on Neuromodulation

Industry observer James Cavuato found one other theme of the NANS conference that is on point for this AFAIK series.

Great to see you there Hannah and good synopsis. One major theme I would add is the response — in several sessions — to recent insurance industry attacks on neuromodulation. There are certainly areas where this industry can improve but for the insurance industry to complain about bias in clinical studies strikes me as the pot calling the kettle black.

You can find the coverage in Cavuato’s Neurotech Business Report.

https://www.neurotechreports.com/pages/JAMA-SCS-critical.html

A highly critical report published last month in JAMA Neurology casts doubt on the effectiveness of spinal cord stimulation for chronic pain. The report has raised concern among SCS vendors and pain doctors, some of whom challenge the findings and the methodology of the report and others who accept some of the criticism as fair game.

https://www.neurotechreports.com/pages/publishersletterJan23.html

One of the most hotly discussed topics at the recent meeting of the North American Neuromodulation Society was how to respond to recent negative reports about neuromodulation, and in particular, two recent studies published in the Journal of the American Medical Association and JAMA Neurology [NBR Dec 22 p1].

For past dispatches, see the AFAIK Archive.