ADAPT-PD Global Study Designed to Demonstrate Safety &
Efficacy of Automated Therapy Which Responds to Brain Signals in
Parkinson's Disease Patients
DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced the first enrollment in ADAPT-PD (Adaptive
DBS Algorithm for Personalized Therapy
in Parkinson's Disease), its trial evaluating the
safety and efficacy of adaptive deep brain stimulation (aDBS) in
patients with Parkinson's Disease (PD). Adaptive deep brain
stimulation is an investigational feature of the Percept™ PC
device that could be enabled if approved. The investigational
feature used in this study allows for automated adjustment of brain
stimulation to provide therapy to manage symptoms of Parkinson's
disease based on a patient's clinical state.
The randomized study will take place across 12 study sites
at leading Movement Disorders research centers in the United States, Europe, and Canada. An estimated 36 subjects will undergo
a total evaluation period of 15 months. The primary endpoint of
ADAPT-PD will compare standard continuous DBS (cDBS) to aDBS for
hours of 'On' time without troublesome dyskinesias, a measure of
treatment efficacy versus side effects, as reported by patient
diary. Qualifying subjects in the study will receive cDBS at
baseline followed by randomized evaluation of two different aDBS
algorithms in a blinded manner.
Dr. Helen Bronte-Stewart, the John E. Cahill Family Professor in
the Department of Neurology and Neurological Sciences at
Stanford University and who is the
North American principal investigator for the ADAPT-PD study,
enrolled the first patient at the Stanford Movement Disorders
Center. Dr. Bronte-Stewart and her collaborators previously laid
the foundation for ADAPT-PD by performing the first closed loop
deep brain stimulation studies in Parkinson's disease using an
investigational prototype research-only system (Activa™ PC+S-Nexus
D3). ADAPT-PD represents an evolutionary leap from these early
studies in that sensing of brain signals and automated adjustment
of stimulation are performed by using unlocked investigational
features of the commercially available Percept PC DBS device,
allowing patients in the study to be both treated and measured
while outside the clinic.
According to the Parkinson's Foundation, more than 10 million
people worldwide are living with Parkinson's disease and while
similar, the progression of symptoms is often different from one
patient to another due to the diversity of the disease. People with
PD may experience tremor; slowness of movements (bradykinesia);
limb rigidity; gait and balance challenges.
DBS is a well-established, safe and effective therapy for the
treatment of motor symptoms in PD, including tremor (shaking);
slowed movement (bradykinesia); and stiffness (rigidity) when
medications aren't as effective as they used to be. Opportunities
exist to improve the efficacy of DBS therapy. Current
commercially-approved DBS systems deliver stimulation continuously
(cDBS) and are adjusted manually within physician-defined limits to
optimize therapy for the patient. In contrast, aDBS therapy may
individualize and optimize PD therapy for the same motor symptoms
as with cDBS by automatically adjusting stimulation within
physician-defined limits, based on brain signals detected by the
DBS system. ADAPT-PD will be using the Percept PC DBS system with
investigational aDBS feature. While the aDBS feature is
investigational and has not been approved for commercial use, the
Percept PC device (cDBS) was approved by the FDA in June 2020. The Percept PC device (cDBS) utilizes
proprietary BrainSense™ technology making it the only DBS system
with the ability to capture patient-specific brain signals. The
sensing feature of the Percept PC system is intended for use in
patients receiving DBS where chronically-recorded bioelectric data
may provide useful, objective information regarding patient
clinical status. Clinical benefits of brain sensing have not been
established.
"Percept PC was developed with a significant amount of
capabilities built into its system. We see this technology evolving
to deliver even more value over time. The recently initiated
ADAPT-PD is the first trial to gather clinical evidence to unlock
those capabilities," said Mike Daly,
vice president and general manager of the Brain Modulation
business, which is reported as part of the Restorative Therapies
Group at Medtronic. "Additionally, stimulation adjusted based on
patient need, aDBS, could reduce total power output and possibly
extend the life of the device."
Medtronic is a pioneer in DBS, developing a small,
pacemaker-like device, placed under the skin of the chest or
abdomen, to send electronic signals to an area in the brain that
controls movement. DBS may help control movement symptoms
associated with PD when medications are no longer as effective as
they used to be. To date, more than 175,000 patients have been
implanted with Medtronic DBS devices for management of Parkinson's
symptoms and other conditions such as Essential Tremor, Epilepsy,
Dystonia and OCD.
"aDBS technology will allow DBS to be responsive in real-time,
communicating with the patient's brain, as needed - which could
reduce the amount of programming burden on a clinician," added
Professor Andrea Kühn, head of
Movement Disorders and Neuromodulation, Charité University
Hospital, Berlin. Professor Kühn
is one of the leading scientists on electrophysiological markers
for PD and designers of the ADAPT study; her team at the Charité,
Universitätsmedizin Berlin
implanted the first Percept PC DBS patient in the world.
About Medtronic DBS Therapy
DBS therapy uses a
surgically implanted medical device, similar to a cardiac
pacemaker, to deliver electrical stimulation to precisely targeted
areas of the brain as adjunctive treatment for several neurological
disorders. Medtronic DBS systems were the first approved for
full-body MRI scans under specific conditions in the United States. Since 1997, more than
175,000 Medtronic DBS devices have been implanted worldwide.
DBS therapy is currently approved in many locations around the
world, including the U.S. and Europe, for the treatment of disabling motor
symptoms of recent and longer-standing Parkinson's disease,
essential tremor, and epilepsy. The therapy is also approved in the
U.S. under Humanitarian Device Exemption (HDE) to treat chronic
intractable primary dystonia and severe, treatment-resistant
obsessive-compulsive disorder.
The FDA-approved indication for Parkinson's disease is as
follows: Bilateral stimulation of the internal globus pallidus
(GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy
for Parkinson's Disease is indicated for adjunctive therapy in
reducing some of the symptoms in individuals with
levodopa-responsive Parkinson's disease of at least 4 years'
duration that are not adequately controlled with medication,
including motor complications of recent onset (from 4 months to 3
years) or motor complications of longer-standing duration.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
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SOURCE Medtronic plc