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Informed Consent

Please sign and date form below.

 

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.

Image Release

I the undersigned hereby grant BiomedRx permission to use my likeness in photograph and video in all of its publications, including but not limited to all of BiomedRx’s printed, video, and digital publications. I understand and agree that any photograph or video using my likeness will become the property of BiomedRx and will not be returned. I understand that since my participation with BiomedRx is voluntary, I will receive no financial compensation.

I hereby irrevocably authorize BiomedRx to edit, alter, copy, exhibit, publish or distribute this media for purposes of publicizing BiomedRx’s programs for any other related, lawful purpose. In addition, I waive the right to inspect or approve the finished product, including written or electronic copy, wherein my likeness appears. Additionally, I waive any right to royalties or other compensation arising out of, or related to, the use of the media.

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.

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