Informed Consent
Soliciting the services of BiomedRx Biomagnetism or the BiomedRx Health Center indicates acceptance of the terms and conditions listed below herein.
This document contains important information
about Neurofeedback (also known as EEG biofeedback or Neurotherapy),
Cranial Electrostimulation Therapy, Biomagnetic Pair Therapy, and the policies
of the BiomedRx Health Center related to Neurofeedback Cranial
Electrostimulation Therapy, and Biomagnetic Pair Therapy provided through our
office.
1)
Benefits and Risks of Neurofeedback
Neurofeedback as a method of treatment has
been around for over 30 years, although it has gained attention mostly in the
past few years. It has been used for a variety of conditions which appear to be
associated with irregular brain activity including attention deficit disorder
with and without hyperactivity. The procedure has also shown promise with
certain behavioral disorders, sleep disorders, depression, anxiety, chronic
pain, minor head injury and seizure disorder. In the reported research most,
subjects benefit from neurofeedback to some extent. Nonetheless, no
representation is made that every client will improve from training.
Our work and studies in the literature suggest that the positive effects of
Neurofeedback last over time. However, clients have, on occasion, sought a few
“tune-up sessions” months and years later, which appear to be helpful. Clients
may need a few “tune-up sessions” after a health or psychological trauma.
Clients who have had head injuries after treatment appear to lose some of the
benefit. It is unclear whether this reflected the undoing of earlier training
or was the result of new damage.
In regards to risks or harm, there is no evidence, either from our experience
or from the literature and research, that treatment is harmful. It in
non-invasive and painless. Some clients have reported that training seemed to
cause a temporary worsening in some symptoms including feeling more anxious,
more distractible, having more difficulty sleeping, etc. These changes were not
serious and can be corrected by shifting the brain wave target range and
electrode locations. Typically, these problems resolve quickly and on their
own. It is very important that you keep us informed of any changes or negative
effects, even if they seem unconnected to the Neurofeedback, so that training
can be modified for you.
2) Neurofeedback and Medications
You should also be aware of the relationship between Neurofeedback and
medications. Obviously, many people undergo Neurofeedback with the goal of
reducing or eliminating the need for medications. However, do not stop or alter
your medications without consulting your physician. Also, be aware that
Neurofeedback could affect your body’s response to other medications you are
taking for conditions unrelated to the ones for which you are undergoing
Neurofeedback. Should new symptoms appear to be developing, it is your
responsibility to keep us informed of them as well as to inform your physician.
3) Neurofeedback Procedures
You need to be aware that Neurofeedback training requires the placement of
surface electrodes on the scalp for the express purpose of recording the EEG
and using this signal to provide feedback to the brain in the form of a video
display or games. There is a very remote possibility of skin irritation from
the electrode cream that is used to prepare the skin and attach the electrodes.
The client needs to report any discomfort during or after the session to the
clinician/technician so that the treatment modality can be altered in the best
interest of the client. Please note that all equipment and preparations used
during the delivery of Neurofeedback treatments at The BiomedRx Health Center
are all high-quality, medical grade materials. The techniques used to prepare
the skin and attach the electrodes have been used at numerous clinics and
research institutions for many years and no deleterious side effects have been
reported. It is a universally used procedure for the recording of the EEG, and
a necessary tool for the evaluation of brain function in various contexts. The
client can remove the electrodes at any time if they so desire. We do NOT
introduce any information into the brain AT ANY TIME. There is NO risk of
electric shock from this procedure.
4) Schedule and Length of Treatment
Sessions are approximately 45 minutes in
length; with 30 minutes (approximately) for the Neurofeedback training and 15
minutes for set-up, clean up and progress reports. Sessions are typically
scheduled two times per week. The average length of training sessions needed is
20-40 sessions, with 20 sessions being average. Most individuals will begin to
notice changes after just a few sessions, but in some challenging cases, major
benefit will not be noted until after several weeks.
5) Fees
A single Neurofeedback session is $150.00
per session. In most cases testing is necessary as one means of measuring
progress. The other measures of progress will be symptom amelioration and
weekly client report.
A full assessment session may include:
✓
Intake;
✓ Full
History Interview;
✓ QIK
Test and discussion of results;
✓
Initial Training and Education session.
Follow up QIK Test (administration of test and results): $125.00
Other testing (as needed): fees determined by testing required
We do not accept insurance. However,
we are happy to provide an itemized bill with appropriate insurance codes for
you to submit to your insurance company for reimbursement. Please be aware,
some insurance companies will not reimburse you for EEG Biofeedback
(Neurofeedback) services.
6) Missed Appointments
At the BiomedRx Health Center our highest goal is to help our clients gain the
success that they desire. In order to achieve this goal and to be efficient for
our clients we must be very organized with our schedule. Our office staff will
do their utmost best to schedule all necessary appointments for you. Once an
appointment time is scheduled that time will be reserved specifically for you.
If you cannot keep your appointment, please contact our office at least 24
hours in advance to reschedule. If you miss an appointment without giving us 24
hours’ notice you will be charged a fee.
7)
Clinicians and Technicians
The BiomedRx Health Center hires technicians to assist in administering
Neurofeedback treatments. Our technicians are fully trained in appropriate,
ethical and caring behavior with clients and how to correctly administer
Neurofeedback training. All of our technicians must pass a rigorous screening
process before they are hired. Our technicians follow a carefully outlined
treatment protocol which is determined by the licensed clinician. At no time do
technicians make treatment decisions without the supervision of a licensed
clinician. At times your Neurofeedback training may be done with a clinician
and at times it may be done with a technician. We always make sure that whoever
does your training with you does so in a professional manner and with your
utmost care in mind. All our technicians report, via careful clinical notes and
supervision and case management meetings, ALL client sessions and treatment
progress to the BiomedRx Health Center clinicians. Our goal at BiomedRx is to
work together as a team to provide you, our client, with the best possible
treatment experience and the best possible outcome.
8) Affiliations and Consultation
Our Neurofeedback licensed clinicians are professionally affiliated with EEGInfo and Othmer Certification.
EEGInfo is a world-renowned Neurofeedback group that
is known for their cutting-edge techniques in the field of Neurofeedback. With
certain cases, your clinician may find the need to professionally consult with
other highly trained professionals about treatment planning. This means that
your clinician may consult with professionals in the EEGInfo
group and/or the BiomedRx Neurofeedback group regarding your diagnosis,
symptoms and/or Neurofeedback training. This consultation is done to provide an
even better experience and treatment outcome for our clients.
At no time will your clinician ever disclose your name or any identifying
information, unless specific written consent is given by you. Agreements Please
initial the following items to indicate that you have read, understand and been
offered the opportunity to discuss any questions that you have pertaining to
these items with your clinician.
By signing this form, you indicate your
understanding of the principles set forth here in regards to:
_____ 1) benefits and risks;
_____ 2) medications;
_____ 3) procedures;
_____ 4) expectations with regard to length of treatment;
_____ 5) fees;
_____ 6) policies regarding missed appointments;
_____ 7) technicians and clinicians;
_____ 8) consultation with other professionals.
Furthermore, by signing this form you waive any claim of damages due to the
training, including worsening of the condition for which the training was
undertaken, claimed side effects or the failure to improve with training. In
addition, you agree to hold The BiomedRx Health Center and its associates
harmless from all claims associated with such training.
9)
Cranial Electrotherapy Stimulation
The MindAlive David
Delight Pro is a medical device that offers Microcurrent Electrical Therapy
(MET) for pain and Cranial Electrotherapy Stimulation (CES) for the management
of anxiety, depression, and insomnia. The current is applied by earclip electrodes. People generally report a pleasant,
relaxed feeling during and after treatment. You may also experience a mild
tingling sensation at the electrode site. If the current is too high you may
experience dizziness and nausea which can be alleviated by reducing the
current.
While the MindAlive David Delight Pro is effective
when used correctly for 9 out of 10 people, it will not work for everyone. Both
pain control and anxiety reduction are usually experienced during a single
treatment, but may be experienced hours after. Insomnia is usually improved
after the initial treatment but may take 3 weeks. Most people can use it at
bedtime. However, some people find they must conduct their 20-42-minute
treatment at least 3 hours prior to bedtime because treatment may interfere
with sleep. Depression usually takes 3 weeks or more of daily treatment to
experience significant improvement, but may take considerably longer. After the
condition is under control, use of The MindAlive
David Delight Pro 2-3 times per week or less is usually sufficient to maintain
good results.
Following treatment there are usually no limitations imposed so most users can
resume normal activities immediately. Some users may have a response that may
affect their ability to perform potentially hazardous tasks, such as driving a
motor vehicle or heavy machinery for up to several hours after treatment.
As with any therapeutic intervention, not all people will respond to The MindAlive David Delight Pro treatment. The degree of
efficacy will vary with the nature of the problem being treated, the overall
health of the person, and with the method of treatment.
Contraindiciations
The The MindAlive
David Delight Pro may affect the operation of implanted demand type cardiac
pacemakers and implanted defibrillators. Do not stimulate directly on the eyes,
or press the probes over the carotid sinus (on the neck near the larynx).
Precautions
External use only. Caution is advised in cases where other forms of pain
control would not be used; such as to retain the beneficial aspects of pain for
diagnosis or in cases where people may overuse pain-controlled areas. Safety of
stimulation has not been established during pregnancy.
Adverse Effects
Adverse effects are usually mild and self-limiting. Adverse effects from data
on approximately 8,792 patients participating in 144 controlled studies, open
clinical trials, and uncontrolled conditions, and by physician survey and
reasonably associated with the use of CES are dizziness (6 cases, .07%), skin
irritation/electrode burns (6 cases, .07%), and headaches (9 cases, .10%).
Prolonged CES treatment at currents higher than necessary may cause dizziness
or nausea that can last for hours to days. Treatment immediately prior to going
to sleep may cause difficulty sleeping. Paradoxical reactions such as increased
anxiety, and sleep disturbances may occur, but are rare.
By signing this form, I consent to the MindAlive
David Delight Pro microcurrent and/or cranial electrotherapy stimulation
treatment. I understand that this treatment has a small risk of mild side
effects. I will use the treatment as prescribed. My signature guarantees that I
do NOT have an implanted demand type cardiac pacemaker or implanted
defibrillator. To the best of my knowledge I am NOT pregnant.
Benefits
While I am aware and accept
that no guarantees about the results have been made, the BiomedRx Neurofeedback
and Cranial Electrotherapy Stimulation systems have been shown in clinical use
to reduce symptoms in a wide range of conditions, including: anxiety,
depression, post-traumatic stress disorder, ADD, substance abuse, autism and
traumatic brain injury. BiomedRx Neurofeedback and Cranial Electrotherapy
Stimulation have also been found to result in improvement in athletics and
other areas or performance. BiomedRx Neurofeedback and Cranial Electrotherapy
Stimulation are not medical treatments and are no substitute for effective
standard medical treatment. If medical treatment is necessary, you agree to
seek it if encouraged to do so.
Safety
While the long-term effects
of Neurofeedback and Cranial Electrotherapy Stimulation as we use it is
unknown, for reference, a double AA battery held against the forehead is at
least 1,000 times stronger than the Cranial Electrotherapy Stimulation signal.
Earlier versions of technologies similar to Cranial Electrotherapy Stimulation
have been in existence since the early 1990’s, yet we are not aware of any
reports of someone being worse from having completed a course of treatment
using Cranial Electrotherapy Stimulation.
Side Effects
1.
Temporary
side effects, especially early on, are not uncommon. In early sessions it is
common for the brain to be overly “reactive” or get overly stimulated. The four
most common “side effects” are
a. Tired
b. Wired (easily excitable)
c. “Spacey”, or lightheaded
d. Headache
2.
These
side effects are usually mild and typically last from minutes to hours,
occasionally for a day, and very rarely for up to a few days. They are always
temporary.
3.
There
may also be a temporary change in sleep with more vivid dreams.
4.
It
is possible to have a temporary flare-up of presenting symptoms.
5.
It
is possible that anything you have experienced in the past, including anxiety,
tics and even physical discomfort may temporarily return. These experiences are
always temporary, typically lasting from a few minutes to a few hours and
rarely up to a few days.
6.
I
understand that if I do experience side effects, that in subsequent sessions
modifications will be made so that side effects will be absent or reduced. Like
giving medication, the dosage often needs to be adjusted, sometimes several
times, based on response.
7.
There
have been reported seizures in those who have had prior seizures. However, Neurofeedback
and Cranial Electrotherapy Stimulation appear to act as an anticonvulsant and
has led to medically supervised decreases in anticonvulsants.
8.
While
Cranial Electrotherapy Stimulation can be used to treat migraines, it also
possible to provoke a migraine.
9.
I
understand that I am a voluntary participant and may withdraw my consent and
discontinue sessions of Neurofeedback and Cranial Electrotherapy Stimulation at
any time.
Initial improvements are
temporary, but with additional treatment these improvements typically last
longer and longer until they are more “enduring”. We do not guarantee full or
permanent resolution of symptoms. Some clients need “tune-ups”, or additional
sessions. Because improvements are initially temporary, I understand that if I
do not complete a full course of sessions that initial improvements are not
likely to continue.
I also understand that most
people typically require about 20 sessions but that this number can vary. In
some conditions, including autism, severe stroke or traumatic brain injury,
certain learning disabilities, etc., patients may require more sessions that
can continue for years.
I have been advised that I
should avoid making changes in my medications without the express written
approval of my medical doctor. Further, I understand that I have been advised
of the importance of advising my Neurofeedback/CES clinician or technician of
any/and all change[s] in medication and/or dosage.
I acknowledge that I have
read and understand this consent form and that the clinician or technician has
fully answered all my questions to my satisfaction. I authorize The BiomedRx
Health Center and associates and assistants, to perform Direct Neurofeedback
sessions.
Biomagnetic
Pair Therapy
The Biomagnetic Pair (BP)
is a therapeutic technique developed by the Mexican scientist Dr. Isaac Goiz
Duran more than 27 years ago. The technique focuses on eliminating the root
causes of a disease, those that exacerbate it or impede rehabilitation of the
patient. This is done through the application of permanent artificial magnets
in different parts of the body that are in “Biomagnetic Resonance” and by
adhering to the methodology prescribed by the discoverer of this technique.
With this technique it is possible to treat many ailments including contagious
infectious, chronic degenerative, metabolic, dysfunctional, autoimmune,
psycho-emotional and tumoral diseases, as well as poisonings. The
implementation of the technique reduces clinical symptoms, rehabilitates
different functions of the body and reestablishes the person´s health and
wellbeing. The result in many cases is a clinical improvement in the patient’s
condition, without experiencing the side effects of conventional treatments,
drug poisoning due to overdoses or anaphylaxis, antimicrobial resistance. It
also helps reduce the risk of infection, hemorrhages or surgery complications,
as well as reducing hospital stays, recovery time and rehabilitation. The Biomagnetic
Pair is a simple technique that anyone can perform and that should be learned
from first hand sources, so that the knowledge and information acquired can be
applied properly for the good of all people.
Permission
for Sessions:
I acknowledge and agree that I have been given an opportunity to ask questions
regarding Neurofeedback, Cranial Electrotherapy Stimulation, and Biomagnetic
Pair Therapy, and that these questions have been answered to my complete
satisfaction and I hereby consent to evaluation and application of Neurofeedback,
Cranial Electrotherapy Stimulation and Biomagnetic Pair Therapy as discussed
hereinabove. I accept and
give my consent to the BiomedRx Health Center, and his colleagues to scan me
using the Biomagnetic Pair technique and to register my personal information
for non-profit purposes. I have been informed that this is not allopathic
medicine and that after the scan I may experience the following symptoms:
increased urination, fatigue, weakness, low grade fever, headache, dizziness,
diarrhea, clumsiness, muscular pain and sleepiness. All these should be mild
and shouldn´t last more than 48 to 72 hours after the Biomagnetic Pair scan has
been done. If they last longer or are more severe, please call 424-204-2382 for
guidance and support. I understand that I have not been given any guarantees or
promises regarding the results of the treatments I am about to undergo, nor
that I will be given a diagnosis, a change or alteration of the prescription
medications I am currently taking and that the scan is being done only to
stabilize, normalize and balance the body´s bioelectric system for homeostatic
purposes.
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photograph or video using my likeness will become the property of BiomedRx and
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authorize BiomedRx to edit, alter, copy, exhibit, publish or distribute this
media for purposes of publicizing BiomedRx’s programs
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inspect or approve the finished product, including written or electronic copy,
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I hereby hold harmless and
release and forever discharge Devin Lockett, BiomedRx Inc., and the BiomedRx
Health Center from all claims, demands, and causes of action which I, my heirs,
representatives, executors, administrators, or any other persons acting on my
behalf or on behalf of my estate have or may have by reason of this
authorization. I also hold harmless and release and forever discharge Devin
Lockett, BiomedRx Inc., and the BiomedRx Health Center from all claims,
demands, and causes of action which I, my heirs, representatives, executors,
administrators, or any other persons acting on my behalf or on behalf of my
estate have or may have concerning the treatment I receive at the BiomedRx
Health Center. I understand that there are no refunds of costs for the services
provided by the BiomedRx Health Center, and that all sales are final.
I am at least 18 years of
age and am competent to contract in my own name. I have read this release and
informed consent before signing below and I fully understand the contents,
meaning, and impact of this release and informed consent.
___________________________________________________ ___/___/_____
Signature Date
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Printed name