Informed Consent

WHAT IS IASIS MCN: Micro Current Neurofeedback?

IASIS MCN: Micro Current Neurofeedback supports the brainwaves, at rest, to become quieter, and at work, more flexible in their functioning. This involves measuring and recording electrical signals from the scalp and using the frequencies of those signals to guide the speed of a feedback signal. The extremely weak electromagnetic pulses come from the EEG cables and will be neither visible nor “feel-able”. The recorded EEG signals influence the electromagnetic feedback; and the feedback in turn, changes the quantity and frequency of the recorded brainwave signals. While the overall record of the use of IASIS MCN: Micro Current Neurofeedback is quite successful, there can be no guarantee of success in your particular instance. Before you give your consent to be treated, please read the following and ask as many questions as are necessary for you to understand this process.

BENEFITS:

The IASIS MCN: Micro Current Neurofeedback system has been shown in clinical use to bring about significant improvements in a relatively brief process of therapy in physical and emotional rehabilitation. Significantly shorter rehabilitation is of great importance in time, money, and patient hopes

You may experience an end to the problems affecting you since your head injury and/or psychological trauma, and to the problems that have interfered with your ability to function in your life.

The return of clarity, energy during the day, sleeping at night, a sense of humor, motivation to get things done, ease of getting things done, memory, ability to read and listen with little or no distraction, and the absence of depression, irritability, impatience, and explosiveness have been observed repeatedly.

ALTERNATIVES:

None of the alternative treatments to IASIS MCN: Micro Current Neurofeedback treatment appear to act as rapidly as IASIS MCN: Micro Current Neurofeedback. Other forms of brainwave biofeedback, also known as EEG biofeedback, are also being used to treat the effects of head injuries.

While the long-term effects of using electrical field feedback as we use it is unknown, for reference, a cellular telephone generates a signal at least millions of times the power of the IASIS MCN: Micro Current Neurofeedback feedback signal. The intensity of our field is less than a trillionth of a watt and is on for a few seconds during each session. A background signal approximately a thousand times less than the feedback signal is also present as soon as the EEG begins to read the brainwaves. No instances of problems with the emissions from the feedback have ever been recorded.

IASIS MCN: Micro Current Neurofeedback is not a medical treatment and is no substitute for effective standard medical treatment. If you need medical treatment, you are encouraged to seek it.

If you are taking medication, it will be necessary to stay in close contact with your physician. It has been our observation that the need for these medications often decreases, and people may start having side. The types of medication include those for: sugar problems (diabetes), thyroid problems, migraines and other headaches, seizure problems, emotional, thinking, or perceptual problems, movement problems, spasticity and low or high blood pressure

Anyone who is medically unstable should ask the therapist to consult your physician before you undertake this process. And it is important to report any odd or uncomfortable sensations or experiences to the therapist and to your physician.

IASIS MCN: Micro Current Neurofeedback has been used with approximately 75,000 patients. In clinical use, the IASIS MCN: Micro Current Neurofeedback device has been observed to be significantly helpful for the following issues:

• Depression

• Post-traumatic stress disorder symptoms of:

  • anxiety

  • hypervigilance (or vigilant alertness)

  • fears

  • anger/rage

  • deep sadness

  • irritability and restlessness

  • feelings of helplessness

  • sleeping problems

• Obsession/compulsions

• Closed-head injury symptoms of:

  • irritability and explosiveness

  • loss of energy, motivation, and sense of humor

  • problems of clarity, thinking and estimating clearly

  • memory difficulties

  • sleeping problems

  • being unable to do more than one thing at a time

  • problems following conversations and reading material

  • problems absorbing and taking to heart what people say

• Spasticity, movement, and balance problems caused by stroke and in some cases spinal cord injury

• Chronic fatigue syndrome

• Fibromyalgia pain

• Attention-deficit and hyperactivity problems

• Autism in children and young adults

THE IASIS MCN: MICRO CURRENT NEUROFEEDBACK PROCEDURE:

The brainwave recording process some electrode gel or cream will be applied to the skin on certain sites on the head where sensors are attached behind the ears, to improve the quality of the recording. A third sensor will then be pressed to your neck as the reference or ground, and two additional sensors are moved to other scalp sites. No invasive procedures are used.

The equipment assesses a client’s brainwaves — extremely faint electrical signals measured at discrete locations on the scalp. After a short assessment of these brainwaves by a clinician, the equipment itself then generates extremely faint, battery-generated signals that the brain may respond to in beneficial ways.

During the sessions you will be asked to sit quietly. You will not be asked to think of anything in particular, or to learn anything. In fact, you will be asked to not think of any imagery or constructive thoughts. We have found that this can slow treatment progress. Your brain can detect the feedback, although you will not see or feel anything.

You will be asked to keep track of discomforts or side effects experienced during your treatment.

You will also be asked about your most prominent symptoms before treatment and how they change.

DURATION:

You will have as many sessions as you need, each session lasting between one second and several minutes duration. The rest of the time will be spent, as needed, talking about what effects, if any, the feedback has had on you. The initial session may take 45-60 minutes in total or shorter as needed. Follow up sessions may take 25-30 minutes.

It is difficult to predict how many IASIS MCN: Micro Current Neurofeedback sessions will be required. The following estimates are based on our experience; some patients have needed fewer sessions, and occasionally a few more:

If your problem came on suddenly after a life of high functioning and you are comfortable with the longer periods of feedback, you can expect 15 – 20 sessions. This is only an average range; however, treatment may require more or less than the average figures.

If you have a lifelong history of multiple problems, you may need many more sessions.

RISKS:

Electromagnetic Field Side Effects:

The intensity of our field is less than three trillionths of a watt or 3 picowatts, and less, and is on for a few seconds during each session. A background signal approximately a thousand times less than the feedback signal is also present as soon as the EEG begins to read the brainwaves. For reference, a cellular telephone generates a signal at least millions of times the power of the IASIS MCN: Micro Current Neurofeedback feedback signal. Although the long-term effects of using electrical field feedback as we use it is unknown, no instances of problems with the emissions from the feedback have ever been recorded.

Seizures

With very few exceptions, seizure activity has not been a primary reason to seek treatment with IASIS MCN: Micro Current Neurofeedback. There have been reported seizures in those who have had prior seizures. However, IASIS MCN: Micro Current Neurofeedback appears to act as an anticonvulsant and has led to medically supervised decreases in anticonvulsants.

One of the biggest sources of seizure is a sudden decrease in anticonvulsants by the patient. We urge patients to consult their physicians and our therapists about their desires to decrease their medications of any kind.

Brief Reactions:

There are some potential risks of discomfort involved in participating in this treatment. On the rare occasions when the feedback is too intense or the feedback periods are too long, you may feel uncomfortable, irritable, tense and anxious. This rarely happens for more than a second at a time. When this happens, please tell the operator and the settings on the equipment can and will be changed to make the feedback less intense and shorter in duration, to the extent that you are once more comfortable.

Longer Lasting Reactions:

You may experience one- or two-week periods of anger, fear, and irritability during the treatment. You may feel as if you have tremendous energy to do things or feel very tired. These longer-lasting reactions have especially tended to occur with particular feelings that people have been struggling to control for a long time. While these feelings can be intrusive and bothersome, it has been the experience of previous patients that they can still function. At times however, support from your own therapist or physician may be useful and should be relied upon.

You must report any and all medications you use while you participate in the treatment and are not to change your medications without informing your therapist and your physician.

When is Something a Side Effect or a Benefit?

While we have had experience since 1990 with IASIS MCN: Micro Current Neurofeedback and its antecedents, and are familiar with many of its benefits and side effects, it is sometimes difficult to know when a feeling, benefit, or other problem is due to IASIS MCN: Micro Current Neurofeedback, or due to something else happening, such as an on-coming cold, allergy, a stress in your life, or some other kind of physical change in you, completely unrelated to IASIS MCN: Micro Current Neurofeedback. In addition, your own background can play a very big part in the kinds of feelings you have while receiving IASIS MCN: Micro Current Neurofeedback

Here’s a guide for thinking out what a feeling, benefit, or problem is due to: If you find yourself wondering or guessing more than three times about why you are feeling something, it is probably due to either IASIS MCN: Micro Current Neurofeedback or another physical reason. If, on the other hand, you think you know why you are feeling the way you do, trust yourself.

You do not have to know whether something may be due to IASIS MCN: Micro Current Neurofeedback or whether it may be due to something else. If you notice something and wonder about why you are experiencing it, make note of it for later discussion with us.

Please write notes about your feelings and questions and bring them with you to your sessions.

A Perspective on Side Effects from IASIS MCN: Micro Current Neurofeedback Treatment:

Although the unexpected is always a possibility, we have always found that any side effects that have occurred in IASIS MCN: Micro Current Neurofeedback treatment were already familiar ones. In other words, the feelings and medical problems that arose have always been something that the patients have experienced and have had some trouble with in the past.

Those whose medical status is unstable are advised to consult with their physician about becoming more medically stable before undertaking this treatment. IASIS MCN: Micro Current Neurofeedback tends to lower blood pressure, which can complicate some kinds of problems such as orthostatic hypotension.

It is also important to know that when the problems have occurred during IASIS MCN: Micro Current Neurofeedback treatment, many have been a fraction of their former intensity, which means that often they have been more manageable than in the past.

Your comfort is of great importance: so, telling us your feelings at any time will help to reduce the side effects and make sure we can best cooperate with your therapist and/or physician

Between Sessions:

While many people feel energy, ease, clarity, and happiness after an IASIS MCN: Micro Current Neurofeedback session, these positive feelings may precede feelings of fatigue, depression, and anxiety between sessions. Those “rebounding” from good feelings often feel discouraged and doubtful about their ability to finish treatment. The rebound appears to be the brain’s way of struggling to remain in the old, familiar, and dysfunctional state.

As people continue with IASIS MCN: Micro Current Neurofeedback, both the intensity of the good feelings and the unpleasant rebound periods tend to become shorter and less intense until the exaggerated feelings no longer occur. To date there have been no exceptions to this pattern.

Instead, people become clearer about the entire range of feelings they have, instead of staying numb and flat in their emotional responses.

Problem Cycles:

Relief from life-long problems can be uneven. The symptoms can feel sharper, at times, than they were before; they then pass, and tend to rise less in subsequent cycles of rising and fallings. It has been our experience that during each cycle, both therapist and person receiving this treatment can become anxious and filled with doubt about the wisdom of this treatment. It is important to know that no one has remained worse, and all but three per cent have remained the same. The rest have improved. There is no guarantee that you will remain free from these problem cycles.

Considerations after Treatment:

It will be time to discontinue IASIS MCN: Micro Current Neurofeedback when you stabilize and achieve consistently better functioning. You may, however, become used to the stimulation that IASIS MCN: Micro Current Neurofeedback provides you, and go into a slump after you discontinue it. The slumps that have occurred have lasted between a few days and a month and have been less of a problem than those that brought people into IASIS MCN: Micro Current Neurofeedback treatment. During this period your body will become accustomed to being open to its own internal useful stimulation. Most of those who have received IASIS MCN: Micro Current Neurofeedback have continued to improve long after IASIS MCN: Micro Current Neurofeedback has ended.

BENEFITS:

The IASIS MCN: Micro Current Neurofeedback system has been shown in clinical use to bring about significant improvements in a relatively brief process of therapy in physical and emotional rehabilitation. Significantly shorter rehabilitation is of great importance in time, money, and patient hopes

You may experience an end to the problems affecting you since your head injury and/or psychological trauma, and to the problems that have interfered with your ability to function in your work and personal life.

The return of clarity, energy during the day, sleeping at night, a sense of humor, motivation to get things done, ease of getting things done, memory, ability to read and listen with little or no distraction, and the absence of depression, irritability, impatience, and explosiveness have been observed repeatedly.

VOLUNTARY PARTICIPATION:

You are free to withdraw your consent and discontinue participation in the treatment at any time.

CONFIDENTIALITY:

Your identity will not be disclosed without your separate consent, except as specifically required by law. Examples of legal requirements for breaking confidentiality are:

• under court order

• in case of unlawful behavior such as suspected child abuse

• in case you bring legal action against the clinician or the clinician’s staff

With these exceptions, any data released or published will not identify you by name.

If you cannot sign, through physical disability or illiteracy, but are otherwise capable of being informed and giving verbal consent, a third party, not connected with the treatment, or next of kin or guardian may sign for you

LIMITATIONS OF THIS CONSENT:

This signed form may not be used as consent for any other treatment. Participation in any other treatment requires a separate form. All procedures performed under the protocol will be conducted by individuals legally and responsibly entitled to do so.

PERMISSION FOR TREATMENT:

I, a prospective patient, give my full permission to Ronny, supervisor, or other staff of his/her office to use any data collected during the preparation and participation in the IASIS MCN: Micro Current Neurofeedback sessions, and I give up all implied and actual ownership of any data collected. I understand that when data is used, my confidentiality will be protected, and that my identity will not be revealed unless required by law (as outlined previously).

I acknowledge that I have been given an opportunity to ask questions regarding this new treatment and that these questions have been answered to my satisfaction.

Initial here:

I acknowledge that I have read and understand the above information and agree to participate in this treatment.

IASIS MCN: MICRO CURRENT NEUROFEEDBACK ARBITRATION AGREEMENT

Article 1: AGREEMENT TO ARBITRATE: It is understood that any dispute as to medical malpractice, that is as to whether any medical services rendered under this contract were unnecessary or unauthorized or were improperly, negligently or incompetently rendered, will be determined by submission to arbitration as provided by California law, and not by a lawsuit or resort to court process except as state and federal law provides for judicial review of arbitration proceedings. Both parties to this contract, by entering into it, are giving up their constitutional right to have any such dispute decided it a court of law before a jury, and instead are accepting the use of arbitration.

Article 2: ALL CLAIMS MUST BE ARBITRATED: It is also understood that any dispute that does not relate to medical malpractice, including disputes as to whether or not a dispute is a subject to arbitration and procedural disputes will also be determined by submission to binding arbitration. It is the intention of the parties as to all claims, including claims arising out of or relating to treatment or services provided by the healthcare provider including any heirs or past, present or future spouse(s) of the patient in relation to all claims, including loss of consortium. This agreement is also intended to bind any children of the patient whether born or unborn at the time of the occurrence giving rise to any claim. This agreement is intended to bind the patient and the healthcare provider and/or other licensed healthcare providers are preceptorship interns who now or in the future treat patient while employed by, working or associated with or serving as a back-up for the healthcare provider, including those working at the health providers clinic or office or any other clinic or office whether signatories to this form or not. All claims for monetary damages exceeding the jurisdictional limit of the small claims court against the healthcare provider, and/or the healthcare providers associates, association, corporation, partnership, employees, agents and estate, must be arbitrated including, without limitation, claims for loss of consortium, wrongful death, emotional distress, injunctive relief, or punitive damages.

Article 3: PROCEDURES AND APPLICABLE LAW: A demand for arbitration must be communicated in writing to all parties. Each party shall select an arbitrator (party arbitrator) within 30 days and a third arbitrator (neutral arbitrator) shall be selected by the arbitrators appointed by the parties within 30 days thereafter. The neutral arbitrator shall then be the sole arbitrator and shall decide the arbitration. Each party to the arbitration shall pay such party's pro rata share of the expenses and fees of the neutral arbitrator, together with other expenses of the arbitration incurred or approved by the neutral arbitrator, not including counsel fees, witness fees, or other expenses incurred by a party for such party's own benefit.

Either party shall have the absolute right to bifurcate the issues of liability and damage upon written request to the neutral arbitrator. The parties consent to the intervention and joinder in this arbitration of any person or entity that would otherwise be a proper additional party in a court action, and upon such intervention and joinder any existing court action against such additional person or entity shall be stayed pending arbitration.

The parties agree that provisions of the California medical injury compensation Reform Act shall apply to disputes within this Arbitration Agreement, including, but not limited to, sections establishing the right to introduce evidence of any amount payable as a benefit to the patient as allowed by law (Civil Code 3333.1), the limitation on recovery for non-– economic losses (Civil Code 3333.2), and the right to have a judgment for future damages conformed to periodic payments (CCP 667.7). The parties further agree that the commercial arbitration rules of the American arbitration Association shall govern any arbitration conducted pursuant to this Arbitration Agreement.

Article 4: GENERAL PROVISIONS: All claims based upon the same incident, transaction or related circumstances shall be arbitrated in one proceeding. A claim shall be waived and forever barred if (1) on the date notice thereof is received, the claim, if asserted in a civil action, would be barred by the applicable legal statute of limitations, or (2) the claimant fails to pursue the arbitration claim in accordance with the procedures prescribed herein with reasonable diligence.

Article 5: REVOCATION: This agreement may be revoked by written notice delivered to the health care provider within 30 days of signature and if not revoked will govern all professional services received by the patient and all other disputes between the parties.

Article 6: RETROACTIVE EFFECT: If patient intends this agreement to cover services rendered before the date it is signed (for example, emergency treatment) patient should initial here , effective as the date of first professional services.

If any provision of this Arbitration Agreement is held in valid or unenforceable, the remaining provisions shall remain in full force and shall not be affected by the invalidity of any other provision. I understand that I have the right to receive a copy of this Arbitration Agreement. By my signature below, I acknowledge that I have received a copy.

NOTICE: BY SIGNING THIS CONTRACT YOU ARE AGREEING TO HAVE ANY ISSUE OF MEDICAL MALPRACTICE DECIDED BY NEUTRAL ARBITRATION AND YOU ARE GIVING UP YOUR RIGHT TO JURY OR COURT TRIAL. SEE ARTICLE 1 OF THIS CONTRACT.