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NeuroPatntRXX
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YOUR RECLAIM® DBS™ THERAPY FOR OCD
Therapy-specific Patient Booklet
Patient Manual
Rx Only
Humanitarian Device: Authorized by Federal (U.S.A.) law for use as an
adjunct to medications and as an alternative to anterior capsulotomy for
the treatment of chronic, severe, treatment-resistant obsessivecompulsive disorder (OCD) in adult patients who have failed at least three
selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this
device for this use has not been demonstrated.
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Medtronic Confidential
NeuroPatntRXX
Medtronic® and Reclaim® are trademarks of Medtronic, Inc., registered
in the U.S. and other countries.
DBS™ is a trademark of Medtronic, Inc.
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Information for family members or
caregivers
Read this patient manual thoroughly so you
can assist the patient living with Reclaim
DBS Therapy.
The patient should have two patient therapy
manuals. If you do not have both manuals,
contact the patient’s doctor.
Always tell any medical personnel that the
patient has an implanted brain stimulator and
tell them where it is located. If medical
personnel have any questions, they should
contact Medtronic at 1-800-510-6735.
Have the name and telephone number of the
patient’s doctor at hand if you have any
questions or problems.
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2011-07
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Contents
Glossary
7
Manual descriptions
13
Reclaim DBS System for OCD
Benefits and limitations 16
Description of the device
Risks
15
17
19
Warnings
20
Precautions
21
Possible side effects
23
Expected battery life
25
What to expect from your implant
procedure 26
Before surgery 26
Details of your DBS surgery 26
Changes in therapy 29
Control devices
30
Use in specific populations
Index
31
35
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Glossary
Battery – A part of the neurostimulator that
provides the power for your brain stimulation
system. Neurostimulator service life depends
on individual use.
Capsulotomy – A surgical technique that is
intended to lessen the symptoms of
obsessive-compulsive disorder that involves
the destruction of specific groups of cells
within a place in the brain called the internal
capsule.
Clinician programmer – A small computer
that is used to program the Reclaim DBS
System. The doctor can change the therapy
settings using this programmer.
Cognitive behavior therapy (CBT) –
Psychotherapy that emphasizes the
substitution of undesirable thinking patterns
with desirable thinking patterns.
Comorbid psychiatric disorder – A
psychiatric disorder that exists simultaneously
with and usually independently of another
psychiatric disorder.
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Control magnet – A magnet used to turn
your neurostimulator on and off.
Disinhibition – The lessening of inhibition
that results in behavior not normally engaged
in that may go beyond accepted cultural
norms.
Electroconvulsive therapy (ECT) – Therapy
that uses electrodes placed on the outside of
the head to send electric current to the brain
for the treatment of certain mental disorders.
Also called electroshock therapy.
Electrode – A metal piece near the tip of the
lead. Electrodes deliver electrical pulses to an
area of your brain that may alter the way you
feel.
Electromagnetic interference (EMI) –
Electrical or magnetic energy that is strong
enough to interfere with or disrupt your
therapy.
Explant – The removal of an implanted
device. Explantation requires surgery.
Hypomania – A mild form of mania,
characterized by hyperactivity or euphoria.
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Inappropriate euphoria – Feeling very good
even when it isn’t justified.
Lead – A thin wire with protective coating that
has metal electrodes on one end. The
electrodes are placed in your brain and the
other end of the lead is connected to the DBS
system extension.
Neurostimulator – The neurostimulator is the
implanted device that generates and controls
your DBS therapy.
Paraphilias – Psychosexual disorders
characterized by deviant sexual thoughts or
actions.
Patient programmer – A hand-held device
that allows you to turn your therapy on and off.
It may also be used to adjust some stimulation
settings.
Service life – Amount of time that the device
battery is expected to work based on the
programmed parameters, clinician-selectable
features, and how often the device is used by
the patient.
Somatic psychiatric therapies – Therapies
such as electroconvulsive therapy (sometimes
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called electroshock therapy), transcranial
magnetic stimulation, or vagus nerve
stimulation that may generate electromagnetic
interference.
Stimulation – The delivery of electrical
signals to the brain cells. The electrical signals
may alter some of the incorrect messages
processed by the brain in the areas that
control mood and anxiety.
Stimulation target – The area of the brain
where the application of stimulation is most
effective.
Surgical ablation – Surgical destruction of
brain tissue intended to lessen the symptoms
of obsessive-compulsive disorder. An
example is a capsulotomy, which is an
alternative to neurostimulation therapy.
Test stimulation – The time period during the
system implant procedure when brain
stimulation is evaluated to determine how well
it controls your symptoms.
Therapy controller – An electronic remote
control device used to turn your
neurostimulator on and off.
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Manual descriptions
There are two Medtronic DBS Therapy
manuals for OCD patients that you should
receive from your doctor.
• The DBS Patient Therapy Guide, which
contains information about all DBS
therapies.
• The DBS Therapy-specific Patient
Booklet, which contains important DBS
therapy information specific to the
patient’s condition.
The patient manual that describes Medtronic
DBS Therapy includes general information
about using the Medtronic DBS System. For
example, information about Medtronic DBS
System components, the implant procedure,
life after surgery, and general risks and
warnings applies to OCD patients as well as
other patients receiving DBS therapy. It is
important to review this information, in
particular the section dealing with warnings
and precautions. If you are a parent or
caregiver of someone who has received a
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Reclaim DBS System, read this document
and ensure the patient is adequately trained
on the relevant issues, particularly those
relating to general risks, warnings and
precautions.
The supplemental manual (the document you
are currently reading) gives specific
information related to using the Reclaim DBS
System to treat OCD. It provides information
that is not included in the patient manual
describing Medtronic DBS Therapy with your
implanted neurostimulator.
You should also receive a patient manual
instructing you how to operate your therapy
controller or patient programmer, if your
doctor prescribes either optional accessory
for you.
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Reclaim DBS System for
OCD
Some of your symptoms are caused by
abnormal messages being processed by
your brain. Your brain stimulation system
delivers mild electrical stimulation to an area
in the brain that controls mood and anxiety.
Stimulation alters some of the messages as
they are being processed by the brain. This
may relieve the symptoms of your disease.
Your therapy helps you control symptoms. It
is not a cure. When you turn on the brain
stimulation system, it will deliver stimulation
that may decrease your symptoms.
Symptoms will return when the system is
turned off.
Significant OCD symptoms are likely to
persist following Reclaim DBS Therapy.
The brain stimulation system is one therapy
that helps you control the symptoms of your
disease. Other therapies and options include
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cognitive behavior therapy (CBT), medication
therapy, and capsulotomy.
Benefits and limitations
Reclaim DBS Therapy for OCD may help you
manage your symptoms, but it is not a cure.
Significant OCD symptoms are likely to
persist following Reclaim DBS Therapy.
When you turn on the brain stimulation
system, it will deliver stimulation that may
decrease some or all of your symptoms. The
stimulation may also make it easier for you to
engage in cognitive behavior therapy (CBT),
which may also help control your symptoms.
Your symptoms will probably return when the
system is turned off. In some cases,
symptoms may return with an intensity
greater than was experienced prior to the
system implant (See “Rebound effect” on
page 21). You will continue to require
medications to control your OCD.
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Description of the device
Depending on your medical condition, you
may have one or two neurostimulators
implanted, which provide stimulation for the
treatment of OCD.
Your system consists of 2 leads and 2
extensions. Each lead connects to an
extension and each extension connects to a
neurostimulator.
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Figure 1 The implanted Reclaim DBS System
(with 1 neurostimulator).
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Figure 2 The implanted Reclaim DBS System
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Risks
Electroconvulsive therapy (ECT) – The
safety of ECT in patients who have an
implanted deep brain stimulation (DBS)
system has not been established. Induced
electrical currents may interfere with the
intended stimulation or damage the
neurostimulation system components
resulting in loss of therapeutic effect,
clinically significant undesirable
stimulation effects, additional surgery for
system explantation and replacement, or
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Warnings
Side effects during programming or test
stimulation – During test stimulation or a
programming session, some side effects may
occur, including:
• facial flushing or facial muscle
contractions
• increased heart rate
• hyperactivity or euphoria (hypomania)
• increased disease symptoms
Your doctor will select different stimulation
settings until these side effects decrease.
Because these side effects may not appear
immediately, you may be asked to remain in
the clinic for at least 30 minutes after your
programming or test stimulation is complete.
Note: For a complete list of warnings, see
your DBS Patient Therapy Guide.
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Precautions
Long-term safety and effectiveness – The
long-term safety and effectiveness of brain
stimulation therapy for obsessive-compulsive
disorder has not been established.
Rebound effect – If your brain stimulation
system ceases to function for any reason
(eg, battery depletion or exposure to EMI
sources that will shut off the system), your
symptoms will probably return. In some
cases, symptoms may return with an
intensity greater than was experienced prior
to the system implant (rebound effect). If this
occurs, contact your physician immediately
so the status of your system can be
assessed and your condition can be closely
monitored.
Somatic psychiatric therapies – The safety
of somatic psychiatric therapies using
equipment that generates electromagnetic
interference (eg, vagus nerve stimulation)
has not been established.
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Note: For a complete list of precautions, see
your DBS Patient Therapy Guide.
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Possible side effects
Side effects of brain stimulation may include
the following:
• Suicidal ideation and depression
• Increased OCD symptoms
• Changes in mood (positive and negative)
• Increased anxiety
• Gastrointestinal disturbances
• Sensations such as tingling (paresthesia),
smell, or taste
• Dizziness or lightheadedness
(disequilibrium)
• Facial and limb muscle weakness or
partial paralysis (paresis)
• Facial flushing or facial muscle
contractions
• Jolting or shocking sensation
• Numbness (hypoesthesia)
• Increased heart rate
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• Hyperactivity or euphoria (hypomania)
Your doctor should carefully monitor you for
symptoms of depression, anxiety, and/or
hypomania/mania. Such symptoms may
include changes in sleep or eating behavior,
disinhibition, anger, aggression, and a
predisposition to accidents.
Note: Contact your doctor if you experience
side effects such as inappropriate euphoria
or disinhibition.
There is also potential for brain tissue
damage if the stimulation parameters are set
too high. Your physician will be warned when
the stimulation parameters exceed a certain
charge density.
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Expected battery life
Refer to your DBS Patient Therapy Guide for
information on the expected battery life of
your neurostimulator.
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What to expect from your
implant procedure
The following is general information about
how the Reclaim DBS System will be
implanted. Your doctor can provide you with
more specific information about your implant
procedure.
Before surgery
The evening before surgery, you may be
instructed to stop taking all or some of your
medications. You will be admitted to the
hospital either the night before or the
morning of your surgery. You may have all or
part of your head shaved prior to surgery to
help prevent infection.
Details of your DBS
surgery
During the surgery to implant your Reclaim
System for OCD, your doctor will use the
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following techniques to determine the area in
your brain where the leads will be placed.
– You will receive local anesthesia before
this procedure.
– Your surgeon may test stimulate areas
of your brain to check changes in mood
or anxiety levels (ie, OCD symptoms).
You will be awake, but lightly sedated.
This is so you can help determine, along
with your doctor, when your symptoms
are best controlled. Your doctor may ask
you questions about your mood.
– When the best target in the brain is
located, the lead is then passed into the
brain.
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Hole Cap
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Stimulation Target
Lead
Electrodes
Figure 3 The location of the lead in your brain.
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Changes in therapy
There may be changes in the level of your
symptom improvement over time. These
changes may include:
• Less relief or no symptom relief
• Loss of effective stimulation
Your clinician may correct these changes by
programming the brain stimulation system
again. However, surgery may be required to
reposition or replace the lead, replace the
system, or remove the system. You may also
ask your doctor to turn off your
neurostimulation system.
Your condition may improve, may worsen, or
may remain unchanged with stimulation.
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Control devices
Your neurostimulator can be turned on or off
using either a control magnet, a therapy
controller, or a patient programmer. Your
physician will determine which control device
is appropriate for your needs. You will receive
a booklet that tells you how to care and how
to use your control device.
Depending on your individual circumstance,
you may have a sensory experience (tingling,
smell, or taste), feel a slight muscle
contraction, or experience no change at all.
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Use in specific
populations
The safety and probable benefit of this
therapy is not known for:
• Patients with Tourette’s syndrome
• Patients with OCD with a primary
subclassification of hoarding
• Patients whose diagnosis of OCD is
documented to be less than 5 years
duration
• Patients whose YBOCS score is less than
30
• Patients who have not completed a
minimum of 3 adequate trials of first and/
or second line medications with
augmentation
• Patients who have not attempted to
complete an adequate trial of cognitive
behavior therapy (CBT)
• Patients with a previous surgical ablation
procedure (e.g., capsulotomy)
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• Patients who are pregnant
• Patients under the age of 18 years
• Patients with dementia
• Patients with coagulopathies or who are
on anticoagulant therapy
• Patients without comorbid depression and
anxiety
• Patients with neurological disorders
• Patients with other serious medical illness
including cardiovascular disease, renal or
hepatic failure, and diabetes mellitus
Use in patients with comorbid psychiatric
disorders – There are potential risks with
implanting the brain stimulation system in
OCD patients who have comorbid psychiatric
disorders that include:
• bipolar disorder
• body dysmorphic disorder
• expanded personality impulse-control
disorders or paraphilias
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• psychotic disorder
• severe personality disorders
• substance abuse
• the inability to control suicidal impulses or
a history of suicidal attempts
The brain stimulation system may aggravate
the symptoms of comorbid psychiatric
disorders.
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Index
B
Brain stimulation
possible side effects 23
precautions 21
warnings 20
Brain stimulation system
picture of implanted system 17, 18
risks 19
C
Caregivers, information for 3
Control devices 30
D
Description
brain stimulation system 17
Reclaim System 17
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G
Glossary 7
L
Lead
placement in the brain 28
M
Medical personnel
informing of implant 3
Medtronic phone number
for physicians 3
P
Precautions 21
R
Reclaim DBS Therapy
changes in therapy 29
precautions 21
risks 19
warnings 20
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Reclaim System
description 17
picture of implanted system 17, 18
Risks
possible side effects of brain stimulation 23
S
Side effects of brain stimulation 23
Stimulation
possible side effects 23
Stimulation target 28
Surgery
before the procedure 26
details 26
medication 26
test stimulation at implant 27
Symptoms
changes in 29
T
Therapy
changes in 29
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W
Warnings 20
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Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432USA
www.medtronic.com
Tel. 1-763-505-5000
Toll-free 1-800-328-0810
Fax 1-763-505-1000
*MA10554A004*
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© Medtronic, Inc. 2011
All Rights Reserved
MA10554A004