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Sample TMS consent form

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Sample TMS consent form
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES
for addressograph plate
rTMS INFORMATION
My doctor has recommended that I receive
treatment with repetitive transcranial magnetic
stimulation (rTMS).
has explained to me the risks and benefits of
these other options. My doctor has also
explained why rTMS has been recommended
for my specific case.
WHAT IS rTMS ?
PROCEDURE
rTMS stands for “repetitive transcranial
magnetic stimulation.” rTMS is a non-invasive
FDA-cleared medical procedure for the
treatment of depression in adults. rTMS is a
brain stimulation technique that relies on the
generation of brief magnetic fields using an
insulated coil that is placed over the scalp.
These magnetic fields are the same type and
strength as those used in magnetic resonance
imaging (MRI) machines. The magnetic pulses
generate a weak electrical current in the brain
that briefly activates neural circuits at the
stimulation site. rTMS has been shown to be a
safe and well-tolerated procedure that can be
an effective treatment for adult patients with
depression who have not benefitted from
antidepressant treatment.
rTMS therapy involves a series of
treatments. For each rTMS session, I will be
brought into a specially equipped room in the
hospital and seated in the treatment chair.
Before beginning the rTMS procedure, I will be
asked to remove any metal or magneticsensitive objects (e.g., jewelry, keys, credit
cards). Because rTMS produces a loud clicking
sound with each pulse, I will also be required to
wear earplugs for my comfort and safety.
rTMS does not require any anesthesia or
sedation, so I will be awake and alert during
the entire procedure.
The potential benefit of rTMS is that it may
lead to improvements in the symptoms of my
psychiatric condition. I understand that not all
patients respond equally well to rTMS. Like all
forms of medical treatment, some patients
recover quickly, others recover briefly and later
relapse, while others may fail to have any
response to rTMS therapy.
ALTERNATIVES TO rTMS
I understand that there are alternative
treatment options for my condition, including
medications,
psychotherapy,
and
electroconvulsive therapy (ECT). My doctor
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A member of the TMS treatment team will
first position my head in the head support
system. Next, the insulated magnetic coil will
be gently placed over the side of my head. The
TMS staff member will then adjust the TMS
device by delivering a series of pulses until it
gives just enough energy so that my hand
twitches. The amount of energy required to
make my hand twitch is called the “motor
threshold.” Everyone has a different motor
threshold and the treatments are given at an
energy level that is just above my individual
motor threshold. During the procedure, I will
hear a clicking sound and feel a tapping
sensation on my scalp.
Once my motor threshold is determined, the
magnetic coil will be moved to the front side of
my head, over a region of the brain that
scientists think may be responsible for causing
depression. I will receive the treatment as a
series of “pulses,” with a “rest” period between
each pulse series. Treatment sessions typically
last thirty to forty minutes.
Trained staff will be monitoring me during
the entire treatment. I may stop the procedure
at any time.
NUMBER OF TREATMENTS
The exact number of treatments I receive
cannot be predicted ahead of time. The
number of treatments I receive will depend on
my psychiatric condition, my response to
treatment, and the medical judgment of my
psychiatrist. rTMS treatments are usually
administered five times per week, but the
frequency of my treatments may vary
depending on my needs. Typically, patients
who respond to rTMS experience results by the
fourth to sixth week of treatment. However,
some patients may experience results in less
time while others may take longer. I may
choose to end the treatments at any time.
RISKS
As with any medical treatment, rTMS carries
a risk of side effects. However, rTMS is
generally well-tolerated and only a small
percentage of patients discontinue treatment
because of side effects.
During the treatment, I may experience
tapping, facial twitching, or painful sensations
at the treatment site while the magnetic coil is
turned on. These types of sensations are
reported by about one third of patients. I
understand that I should inform staff if this
occurs. The treatment staff may then adjust
the stimulation settings or make changes to
where the coil is placed in order to help make
the procedure more comfortable for me. In
addition, about half of patients treated with
rTMS experience headaches. I understand that
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both discomfort and headaches tend to get
better over time and that the headaches
generally responded very well to over-thecounter pain medications.
Because the TMS device produces a loud
click with each pulse, I understand that I must
wear earplugs during treatment to minimize
the risk of hearing loss. There have been no
reported cases of permanent hearing loss with
properly functioning hearing protection. If I
notice that my earplugs become loose or have
fallen out, I will notify treatment staff
immediately.
As with all antidepressant treatments, there
is a small risk for the emergence of mania with
rTMS therapy. My doctor has informed me of
these symptoms and will monitor me for the
development of these symptoms. If I notice
these symptoms, I will alert my doctor
immediately.
The most serious known risk of rTMS is the
production of a seizure. Although there have
been a few case reports of seizures with the
use of TMS devices, this risk is extremely small,
and there have been no seizures observed with
the use of this particular TMS device.
Nonetheless, I will let my doctor know if I have
a history of a seizure disorder, as it may
influence my risk of developing a seizure with
this procedure. The TMS team follows up-todate safety guidelines for the use of TMS that
are designed to minimize the risk of seizures
with this technique.
rTMS therapy is not effective for all patients
with depression, and there is a risk that my
depression will get worse. Any signs or
symptoms of worsening depression should be
reported immediately to your doctor. You may
want to ask a family member or caregiver to
monitor your symptoms to help you spot any
signs of worsening depression.
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES
rTMS INFORMATION
There are no known adverse cognitive
(thinking and memory) effects associated with
rTMS therapy.
for addressograph plate
x Facial tattoos with metallic or magneticsensitive ink
x Other metal devices or objects implanted in
or near your head
PREGNANCY
The risks of exposure to TMS in pregnancy
are unknown. If I am a woman of childbearing
capacity, I may be asked to take a pregnancy
test before starting treatment.
LONG-TERM ADVERSE EFFECTS
There are no known long-term adverse
effects reported with the use of rTMS.
However, as this is a relatively new treatment,
there may be unforeseen risks in the long-term
that are currently unknown.
METAL IMPLANTS
TMS should not be used by anyone who has
non-removable magnetic-sensitive metal in
their head or within twelve inches of the
magnetic coil. Failure to follow this restriction
could result in serious injury or death. Objects
that may have this kind of metal include:
x Aneurysm clips or coils
x Stents in your neck or brain
x Implanted stimulators
x Cardiac pacemakers or implantable
cardioverter defibrillator (ICD)
x Cardiac stents
x Electrodes to monitor your brain activity
x Metallic implants in your ears or eyes
x Shrapnel or bullet fragments
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FURTHER QUESTIONS
I understand that I should feel free to ask
questions of my doctor or member of the TMS
team about rTMS at this time or any time
during or after the course of my treatment. I
understand that my decision to agree to rTMS
is being made on a voluntary basis and that I
may withdraw my consent and have the
treatments stopped at any time.
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES
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rTMS CONSENT
I have read (or have had read to me) the information contained in this consent form
about rTMS therapy and its potential risks and benefits for the treatment of my
diagnosis of ___________________________. I acknowledge that Dr._______________
has explained the purpose of the procedure, the potential risks and benefits of the
procedure, and the alternatives to rTMS. All my questions regarding the procedure
have been answered to my satisfaction. I understand there are other treatment options
for my condition available to me and this has also been discussed with me.
If during the course of treatment other conditions arise which, in the best judgment
of the medical staff, require emergency treatment, I authorize and request the said
treatment be performed. I further understand that no guarantee of any results has
been made.
I consent to the admission of medical students and other authorized observers
during the treatments, in accordance with ordinary practices of the hospital.
I therefore authorize and request the staff of Johns Hopkins to administer a course
of rTMS treatments to me.
I have read carefully, and I understand, the foregoing.
________________________
______________________
_____________
Signature of Patient:
Signature of Witness:
Date:
____________________________________________________
Signature of Physician/Health Care Provider Securing Consent:
White – Patient Copy
02-849-0007 (9/09)
Canary - Hospital Copy
JHH ID No.
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES
for addressograph plate
rTMS CONSENT
I have read (or have had read to me) the information contained in this consent form
about rTMS therapy and its potential risks and benefits for the treatment of my
diagnosis of ___________________________. I acknowledge that Dr._______________
has explained the purpose of the procedure, the potential risks and benefits of the
procedure, and the alternatives to rTMS. All my questions regarding the procedure
have been answered to my satisfaction. I understand there are other treatment options
for my condition available to me and this has also been discussed with me.
If during the course of treatment other conditions arise which, in the best judgment
of the medical staff, require emergency treatment, I authorize and request the said
treatment be performed. I further understand that no guarantee of any results has
been made.
I consent to the admission of medical students and other authorized observers
during the treatments, in accordance with ordinary practices of the hospital.
I therefore authorize and request the staff of Johns Hopkins to administer a course
of rTMS treatments to me.
I have read carefully, and I understand, the foregoing.
________________________
______________________
_____________
Signature of Patient:
Signature of Witness:
Date:
____________________________________________________
Signature of Physician/Health Care Provider Securing Consent:
White – Patient Copy
02-849-0007 (9/09)
Canary - Hospital Copy
JHH ID No.
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