February 12, 2024 • 15 mins
An interview on spinal cord stimulation for diabetic neuropathy with Michael Jaasma, PhD, Principal Clinical Research Scientist at Nevro.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
David Klonoff (00:19):
Hello, welcome to Diabetes Technology Report.
This is the Diabetes TechnologySociety podcast about
technology.
Today we have a very importantguest who's working on a problem
of diabetes that affects manypeople.
I'm Dr David Klonoff.
I'm an endocrinologist at UCSFand Sutter Health.
(00:41):
My co-moderator, Dr David Kerr,will introduce today's
interviewee.
David Kerr (00:47):
Welcome everyone and great that you can join us.
Today we have Mike Jasmur.
I'm especially pleased thatMike's on this podcast today
because when I was in the UnitedKingdom, I spent every Thursday
afternoon for more than 20years running a clinic dedicated
to the treatment of painfulneuropathy caused by diabetes.
(01:12):
I had lots of ups and downs.
It's an incredibly common,incredibly difficult problem to
deal with.
How did you become interestedin this?
Yeah, well.
Michael Jaasma (01:25):
My background is in biomedical engineering and
through my career I've gotteninto medical devices and
specializing in running clinicaltrials.
I work at Nevro, which has aspinal cord stimulation device
to treat painful diabeticneuropathy, like you just
described.
What really drew me to thistechnology was the profound
(01:47):
impact it has on pain relief.
Our clinical trial hasdemonstrated over 80% pain
relief on average for patientsout to two years follow-up.
Just a profound effect on thisvery difficult to treat problem
for people with diabetes.
David Kerr (02:06):
Do you think that it's underappreciated just the
magnitude of the problem ofpainful neuropathy and how
difficult it is to manage?
Michael Jaasma (02:18):
I think that's very true.
When we look in the literature,the conventional management for
the disease includes gabapentin, pregabalin, deloxetine.
We see reports that those workreasonably well sometimes, but
our experience is that those donot work for the majority of
patients.
Either they don't relieve thepain or they have significant
(02:42):
side effects that cause patientsto not to discontinue use of
those medications.
So I think it's maybe it's anunderreported problem.
It's difficult for us as acompany to figure out who
exactly is seeing these patientsand who is working with them on
their painful diabeticneuropathy.
We're trying to get the wordout that these patients should
(03:05):
be sent to pain managementphysicians who have access to
spinal cord stimulation to treatthis problem.
David Klonoff (03:15):
Michael, could you explain what is spinal cord
stimulation, how does it workand what happens to a patient
who wants to try it?
Michael Jaasma (03:24):
Yes, spinal cord stimulation uses an implantable
device to send small electricalsignals or stimulation to
stimulate the spinal cord andthis essentially blocks or turns
off pain signals that are sentfrom the legs and the hands to
the brain.
The device has two maincomponents there's a pulse
(03:44):
generator which has a battery,it's pacemaker-sized and it
provides the electrical signalsand this is connected and this
is implanted under the skin,either in the lower back or the
buttocks, somewhere in thatregion.
And this pulse generator isconnected to small wires that
are placed in the epidural spaceat the back, so the same part
of the body where, for example,women get an epidural injection
(04:07):
when delivering a baby and thesesmall electrical signals are
sent to the epidural space,which stimulates parts of the
spinal cord to, like I said,block these pain signals from
getting to the brain.
David Klonoff (04:20):
Does everybody receive the same amount or
number of electrical signals andif not, how do you decide how
much electricity to put into thebody?
Michael Jaasma (04:30):
Yes, so there is an optimization period after
the device is implanted.
The magnitude of thestimulation there's a range and
you know it will start off atkind of the typically optimal
level, and then that can beadjusted by the engineers who
(04:51):
work with the patients tooptimize their therapy.
I work at Nevro and we have nowan AI-powered system that
received FDA approval last yearand this then allows the patient
to daily check in on their appand say how they're doing, and
then it goes through a AIalgorithm to figure out if that
(05:11):
therapy should be tweaked tooptimize pain relief even more.
David Kerr (05:17):
Mike, if I was a person with diabetes, with
painful neuropathy, its episodicis unpredictable, as you say,
the treatment is reallydifficult.
But who is the ideal candidatefor your technology?
Michael Jaasma (05:33):
So for our technology it is an implant, so
it's for people who have hadpoor success with conventional
medical management.
So the typical medicationsthose should be tried first.
If those do not work, thenspinal cord stimulation is a
great option.
So what we typically recommendis that patients have at least
(05:57):
five out of ten on a pain scalefor their diabetic neuropathy
pain.
For diabetic neuropathypatients our recommendations are
that they have an A1C10 orunder, so they have reasonable
control at least of their bloodglucose levels.
And those are really the twobig requirements for the device.
David Kerr (06:22):
And when I remember that in the clinic there were
different types of pain.
There was the aludinia, therewas the electric shocks, there
was the deep gnawing in thebones, miserable pain.
Does your technology is equallyeffective of these different
types of pain or is itparticularly suitable for
(06:42):
certain?
Michael Jaasma (06:43):
types?
Yeah, that's a great questionand we definitely find that
patients experience the pain indifferent ways.
What we found is that it worksvery well for all of these types
of pain conditions.
So, like I said, out to twoyear follow-up, we have an
average of 80% pain relief.
And in the field of painmanagement, we talk about
(07:06):
responders to the therapy havingat least 50% pain relief At two
years.
Our therapy, which is nevermakes a high frequency
stimulation, which is animperceptible stimulation
compared to some of the otherlow frequency stimulations out
there, what we found is that theresponder rate is 90% of two
years.
So nine out of ten patients seeat least 50% pain relief in two
(07:29):
years.
It works really well.
And then I think you kind ofalluded to another aspect a lot
of these patients it's not justpain.
You know, there can be othersymptoms tingling, numbness and
we found that our device workswell to treat those symptoms.
And in addition to that, thenumbness, these people often
(07:50):
have reduced sensation in theirfeet, which can lead to diabetic
foot ulcers which eventuallycan lead to amputations, and we
found that we can actuallyimprove sensory function in the
feet of these patients.
We have patients who can't feelanything in their feet.
They get the therapy and nowthey can feel their feet again.
(08:11):
And what an impact that has onpatient's lives of not just
relieving their pain but alsoallowing them to feel their feet
, prevent foot ulcers fromforming but also just go about
their daily activities that theypossibly were afraid to do, do
to fall risk of not feelingtheir feet.
So just a lot of differentimprovements for patients.
David Klonoff (08:35):
Michael, I haven't seen much about other
benefits of spinal cordstimulation besides the very
important feature that itrelieves pain.
Is there much in the literatureabout other benefits?
Are there other benefits?
Michael Jaasma (08:51):
Yeah, and, like I just alluded to, pain is the
main thing.
Spinal cord stimulation istreating and it does very well
at treating and reducing painfor people with diabetic,
painful diabetic neuropathy.
But we're finding, as the fieldis moving forward, we're
looking at all of these otheraspects of clinical benefit.
(09:11):
So when you reduce the pain,you improve quality of life.
We've seen clinicallymeaningful improvements in
quality of life.
We've seen meaningfulimprovements in sleep quality,
we've seen improvements inoverall functioning and for
people with diabetes, what ourdata has shown is that we can
(09:32):
actually help them to reducetheir A1C and reduce their body
weight.
So what we think here ispossibly not the stimulation
itself causing changes in A1C orweight, but reducing pain,
which allows patients to focuson other aspects of their life,
so managing the blood sugars,being more active.
We see all of these kind ofcomprehensive benefits.
(09:55):
And then I also mentionedbefore the sensory improvements
in the feet.
Just you know and not seenbefore, disease modifying.
You know treatment effects andthat's really a huge benefit to
these patients.
David Klonoff (10:13):
Those are all very positive, especially from
my perspective, if you haveimproved A1C and improved weight
.
What sort of risks or sideeffects should people be aware
of before they have one of theseprocedures?
Michael Jaasma (10:26):
And the.
You know it is an implant, sothere is a implantation
procedure, so there's always arisk of infection with the
surgical procedure.
What we found is that the riskof infection in people with
diabetes is similar to that ofthe general patient population
(10:47):
for spinal cord stimulationprocedures.
So that's in the, you know, twoto six percent range for
infection rates, very similar towhat happens with pacemakers
and other similar type devicesthat are implanted under the
skin.
So that's one of the maincomplications, the.
(11:08):
There are other less commoncomplications, just some, you
know residual pain from theprocedure, general surgical
procedure issues that can comeup.
David Kerr (11:20):
Mike, can I just ask you just some practical things?
I mean, how often do you haveto have this replaced?
Can you walk through an airportwithout any, without alarms
going off?
Can you go for an MRI scan withit?
These sort of practical thingsfor people considering having
this procedure.
Michael Jaasma (11:41):
Yeah, good question.
So the device has a battery inthe pulse generator that's
implanted under the skin.
There are non rechargablebattery options out there and
then there are rechargeablebattery options.
There are many more devices nowwith a rechargeable option.
So with the Nevere device it'sa wireless recharging.
(12:03):
So you just wear a belt similarto how you'd wirelessly charge
your cell phone, so you justwear that belt for about 30
minutes a day or an hour everycouple of days to charge your
device.
As far as airport scanners,that's safe to go through those
and there are things that needto be thought about for MRIs.
(12:23):
Most devices now are compatiblewith MRI in some situations and
you know you need to talk to aphysician about those types of
MRI scans.
Mainly, the device can beturned off while the MRI is
being taken.
David Klonoff (12:43):
Mike, would you say that the number of people in
the US who are having a spinalcord stimulation implant is it
increasing?
Is it increasing rapidly?
Is it pretty steady?
What do you think?
Michael Jaasma (12:55):
Yeah, definitely for the diabetic neuropathy
patient population.
The numbers are expanding, withNevera was the first company to
introduce this specifically fortreating painful diabetic
neuropathy, with FDA approval in2021.
The number of patients becomingaware of spinal cord
(13:16):
stimulation for their painfuldiabetic neuropathy is
increasing on a month-by-monthbasis.
We're doing a lot of work toget the word out, both to
patients and to physicians,endocrinologists, podiatrists,
neurologists, family careproviders these physicians that
are really treating diabeticneuropathy.
First for these patientsgetting the word out, there's
(13:40):
definitely more knowledge aboutthe therapy and what it can do.
That's turning into more andmore people getting spinal cord
stimulation.
David Kerr (13:52):
It doesn't have to be diabetes, because of the
painful neuropathy.
I guess this technology worksfor any kind of peripheral
neuropathy that results in pain.
Michael Jaasma (14:05):
That's correct.
The therapy has been shown towork for other types of
peripheral neuropathies.
The initial application ofspinal cord stimulation was for
back and leg pain.
Chronic back and leg pain, thatis the neuropathies, painful
neuropathies.
Normally people with thoseconditions are candidates for
(14:25):
spinal cord stimulation.
David Klonoff (14:27):
Mike, I have one last question for you.
How easy or difficult is it fora person to get coverage from
their insurance company ifthey're thinking of having this
type of procedure or deviceimplanted?
Michael Jaasma (14:42):
Spinal cord stimulation.
For the conditions that wementioned back in leg pain,
painful diabetic neuropathyConditions are covered by all
major insurance providers.
In the US they're also coveredby Medicare for all regions.
Now it's becoming more and moreaccessible for patients.
David Klonoff (15:03):
Michael, I would like to thank you for spending
the time explaining spinal cordstimulation to us today.
I want to thank our audiencefor being part of this podcast.
David Curran, I look forward toyou joining us for the next
version of Diabetes TechnologyReport.
This podcast is available onthe Diabetes Technology Society
(15:26):
website, as well as on Spotifyand the Apple Store.
Until the next podcast, michael, thank you for joining us, and
more to come.
Bye-bye.
David Kerr (15:37):
Thank you, michael, thank you Bye.
Hello, welcome to Diabetes Technology Report.
This is the Diabetes TechnologySociety podcast about
technology.
Today we have a very importantguest who's working on a problem
of diabetes that affects manypeople.
I'm Dr David Klonoff.
I'm an endocrinologist at UCSFand Sutter Health.
(00:41):
My co-moderator, Dr David Kerr,will introduce today's
interviewee.
David Kerr (00:47):
Welcome everyone and great that you can join us.
Today we have Mike Jasmur.
I'm especially pleased thatMike's on this podcast today
because when I was in the UnitedKingdom, I spent every Thursday
afternoon for more than 20years running a clinic dedicated
to the treatment of painfulneuropathy caused by diabetes.
(01:12):
I had lots of ups and downs.
It's an incredibly common,incredibly difficult problem to
deal with.
How did you become interestedin this?
Yeah, well.
Michael Jaasma (01:25):
My background is in biomedical engineering and
through my career I've gotteninto medical devices and
specializing in running clinicaltrials.
I work at Nevro, which has aspinal cord stimulation device
to treat painful diabeticneuropathy, like you just
described.
What really drew me to thistechnology was the profound
(01:47):
impact it has on pain relief.
Our clinical trial hasdemonstrated over 80% pain
relief on average for patientsout to two years follow-up.
Just a profound effect on thisvery difficult to treat problem
for people with diabetes.
David Kerr (02:06):
Do you think that it's underappreciated just the
magnitude of the problem ofpainful neuropathy and how
difficult it is to manage?
Michael Jaasma (02:18):
I think that's very true.
When we look in the literature,the conventional management for
the disease includes gabapentin, pregabalin, deloxetine.
We see reports that those workreasonably well sometimes, but
our experience is that those donot work for the majority of
patients.
Either they don't relieve thepain or they have significant
(02:42):
side effects that cause patientsto not to discontinue use of
those medications.
So I think it's maybe it's anunderreported problem.
It's difficult for us as acompany to figure out who
exactly is seeing these patientsand who is working with them on
their painful diabeticneuropathy.
We're trying to get the wordout that these patients should
(03:05):
be sent to pain managementphysicians who have access to
spinal cord stimulation to treatthis problem.
David Klonoff (03:15):
Michael, could you explain what is spinal cord
stimulation, how does it workand what happens to a patient
who wants to try it?
Michael Jaasma (03:24):
Yes, spinal cord stimulation uses an implantable
device to send small electricalsignals or stimulation to
stimulate the spinal cord andthis essentially blocks or turns
off pain signals that are sentfrom the legs and the hands to
the brain.
The device has two maincomponents there's a pulse
(03:44):
generator which has a battery,it's pacemaker-sized and it
provides the electrical signalsand this is connected and this
is implanted under the skin,either in the lower back or the
buttocks, somewhere in thatregion.
And this pulse generator isconnected to small wires that
are placed in the epidural spaceat the back, so the same part
of the body where, for example,women get an epidural injection
(04:07):
when delivering a baby and thesesmall electrical signals are
sent to the epidural space,which stimulates parts of the
spinal cord to, like I said,block these pain signals from
getting to the brain.
David Klonoff (04:20):
Does everybody receive the same amount or
number of electrical signals andif not, how do you decide how
much electricity to put into thebody?
Michael Jaasma (04:30):
Yes, so there is an optimization period after
the device is implanted.
The magnitude of thestimulation there's a range and
you know it will start off atkind of the typically optimal
level, and then that can beadjusted by the engineers who
(04:51):
work with the patients tooptimize their therapy.
I work at Nevro and we have nowan AI-powered system that
received FDA approval last yearand this then allows the patient
to daily check in on their appand say how they're doing, and
then it goes through a AIalgorithm to figure out if that
(05:11):
therapy should be tweaked tooptimize pain relief even more.
David Kerr (05:17):
Mike, if I was a person with diabetes, with
painful neuropathy, its episodicis unpredictable, as you say,
the treatment is reallydifficult.
But who is the ideal candidatefor your technology?
Michael Jaasma (05:33):
So for our technology it is an implant, so
it's for people who have hadpoor success with conventional
medical management.
So the typical medicationsthose should be tried first.
If those do not work, thenspinal cord stimulation is a
great option.
So what we typically recommendis that patients have at least
(05:57):
five out of ten on a pain scalefor their diabetic neuropathy
pain.
For diabetic neuropathypatients our recommendations are
that they have an A1C10 orunder, so they have reasonable
control at least of their bloodglucose levels.
And those are really the twobig requirements for the device.
David Kerr (06:22):
And when I remember that in the clinic there were
different types of pain.
There was the aludinia, therewas the electric shocks, there
was the deep gnawing in thebones, miserable pain.
Does your technology is equallyeffective of these different
types of pain or is itparticularly suitable for
(06:42):
certain?
Michael Jaasma (06:43):
types?
Yeah, that's a great questionand we definitely find that
patients experience the pain indifferent ways.
What we found is that it worksvery well for all of these types
of pain conditions.
So, like I said, out to twoyear follow-up, we have an
average of 80% pain relief.
And in the field of painmanagement, we talk about
(07:06):
responders to the therapy havingat least 50% pain relief At two
years.
Our therapy, which is nevermakes a high frequency
stimulation, which is animperceptible stimulation
compared to some of the otherlow frequency stimulations out
there, what we found is that theresponder rate is 90% of two
years.
So nine out of ten patients seeat least 50% pain relief in two
(07:29):
years.
It works really well.
And then I think you kind ofalluded to another aspect a lot
of these patients it's not justpain.
You know, there can be othersymptoms tingling, numbness and
we found that our device workswell to treat those symptoms.
And in addition to that, thenumbness, these people often
(07:50):
have reduced sensation in theirfeet, which can lead to diabetic
foot ulcers which eventuallycan lead to amputations, and we
found that we can actuallyimprove sensory function in the
feet of these patients.
We have patients who can't feelanything in their feet.
They get the therapy and nowthey can feel their feet again.
(08:11):
And what an impact that has onpatient's lives of not just
relieving their pain but alsoallowing them to feel their feet
, prevent foot ulcers fromforming but also just go about
their daily activities that theypossibly were afraid to do, do
to fall risk of not feelingtheir feet.
So just a lot of differentimprovements for patients.
David Klonoff (08:35):
Michael, I haven't seen much about other
benefits of spinal cordstimulation besides the very
important feature that itrelieves pain.
Is there much in the literatureabout other benefits?
Are there other benefits?
Michael Jaasma (08:51):
Yeah, and, like I just alluded to, pain is the
main thing.
Spinal cord stimulation istreating and it does very well
at treating and reducing painfor people with diabetic,
painful diabetic neuropathy.
But we're finding, as the fieldis moving forward, we're
looking at all of these otheraspects of clinical benefit.
(09:11):
So when you reduce the pain,you improve quality of life.
We've seen clinicallymeaningful improvements in
quality of life.
We've seen meaningfulimprovements in sleep quality,
we've seen improvements inoverall functioning and for
people with diabetes, what ourdata has shown is that we can
(09:32):
actually help them to reducetheir A1C and reduce their body
weight.
So what we think here ispossibly not the stimulation
itself causing changes in A1C orweight, but reducing pain,
which allows patients to focuson other aspects of their life,
so managing the blood sugars,being more active.
We see all of these kind ofcomprehensive benefits.
(09:55):
And then I also mentionedbefore the sensory improvements
in the feet.
Just you know and not seenbefore, disease modifying.
You know treatment effects andthat's really a huge benefit to
these patients.
David Klonoff (10:13):
Those are all very positive, especially from
my perspective, if you haveimproved A1C and improved weight
.
What sort of risks or sideeffects should people be aware
of before they have one of theseprocedures?
Michael Jaasma (10:26):
And the.
You know it is an implant, sothere is a implantation
procedure, so there's always arisk of infection with the
surgical procedure.
What we found is that the riskof infection in people with
diabetes is similar to that ofthe general patient population
(10:47):
for spinal cord stimulationprocedures.
So that's in the, you know, twoto six percent range for
infection rates, very similar towhat happens with pacemakers
and other similar type devicesthat are implanted under the
skin.
So that's one of the maincomplications, the.
(11:08):
There are other less commoncomplications, just some, you
know residual pain from theprocedure, general surgical
procedure issues that can comeup.
David Kerr (11:20):
Mike, can I just ask you just some practical things?
I mean, how often do you haveto have this replaced?
Can you walk through an airportwithout any, without alarms
going off?
Can you go for an MRI scan withit?
These sort of practical thingsfor people considering having
this procedure.
Michael Jaasma (11:41):
Yeah, good question.
So the device has a battery inthe pulse generator that's
implanted under the skin.
There are non rechargablebattery options out there and
then there are rechargeablebattery options.
There are many more devices nowwith a rechargeable option.
So with the Nevere device it'sa wireless recharging.
(12:03):
So you just wear a belt similarto how you'd wirelessly charge
your cell phone, so you justwear that belt for about 30
minutes a day or an hour everycouple of days to charge your
device.
As far as airport scanners,that's safe to go through those
and there are things that needto be thought about for MRIs.
(12:23):
Most devices now are compatiblewith MRI in some situations and
you know you need to talk to aphysician about those types of
MRI scans.
Mainly, the device can beturned off while the MRI is
being taken.
David Klonoff (12:43):
Mike, would you say that the number of people in
the US who are having a spinalcord stimulation implant is it
increasing?
Is it increasing rapidly?
Is it pretty steady?
What do you think?
Michael Jaasma (12:55):
Yeah, definitely for the diabetic neuropathy
patient population.
The numbers are expanding, withNevera was the first company to
introduce this specifically fortreating painful diabetic
neuropathy, with FDA approval in2021.
The number of patients becomingaware of spinal cord
(13:16):
stimulation for their painfuldiabetic neuropathy is
increasing on a month-by-monthbasis.
We're doing a lot of work toget the word out, both to
patients and to physicians,endocrinologists, podiatrists,
neurologists, family careproviders these physicians that
are really treating diabeticneuropathy.
First for these patientsgetting the word out, there's
(13:40):
definitely more knowledge aboutthe therapy and what it can do.
That's turning into more andmore people getting spinal cord
stimulation.
David Kerr (13:52):
It doesn't have to be diabetes, because of the
painful neuropathy.
I guess this technology worksfor any kind of peripheral
neuropathy that results in pain.
Michael Jaasma (14:05):
That's correct.
The therapy has been shown towork for other types of
peripheral neuropathies.
The initial application ofspinal cord stimulation was for
back and leg pain.
Chronic back and leg pain, thatis the neuropathies, painful
neuropathies.
Normally people with thoseconditions are candidates for
(14:25):
spinal cord stimulation.
David Klonoff (14:27):
Mike, I have one last question for you.
How easy or difficult is it fora person to get coverage from
their insurance company ifthey're thinking of having this
type of procedure or deviceimplanted?
Michael Jaasma (14:42):
Spinal cord stimulation.
For the conditions that wementioned back in leg pain,
painful diabetic neuropathyConditions are covered by all
major insurance providers.
In the US they're also coveredby Medicare for all regions.
Now it's becoming more and moreaccessible for patients.
David Klonoff (15:03):
Michael, I would like to thank you for spending
the time explaining spinal cordstimulation to us today.
I want to thank our audiencefor being part of this podcast.
David Curran, I look forward toyou joining us for the next
version of Diabetes TechnologyReport.
This podcast is available onthe Diabetes Technology Society
(15:26):
website, as well as on Spotifyand the Apple Store.
Until the next podcast, michael, thank you for joining us, and
more to come.
Bye-bye.
David Kerr (15:37):
Thank you, michael, thank you Bye.
Popular Podcasts
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Special Summer Offer: Exclusively on Apple Podcasts, try our Dateline Premium subscription completely free for one month! With Dateline Premium, you get every episode ad-free plus exclusive bonus content.
The Breakfast Club
The World's Most Dangerous Morning Show, The Breakfast Club, With DJ Envy, Jess Hilarious, And Charlamagne Tha God!
Crime Junkie
Does hearing about a true crime case always leave you scouring the internet for the truth behind the story? Dive into your next mystery with Crime Junkie. Every Monday, join your host Ashley Flowers as she unravels all the details of infamous and underreported true crime cases with her best friend Brit Prawat. From cold cases to missing persons and heroes in our community who seek justice, Crime Junkie is your destination for theories and stories you won’t hear anywhere else. Whether you're a seasoned true crime enthusiast or new to the genre, you'll find yourself on the edge of your seat awaiting a new episode every Monday. If you can never get enough true crime... Congratulations, you’ve found your people. Follow to join a community of Crime Junkies! Crime Junkie is presented by audiochuck Media Company.