About FNS

(Flexyx Neurotherapy System)

 

Information and Treatment Consent for Adults

 

 

 

Address of the Center

 

 

 

 

 

 

 

Informed Consent

 

You are seeking FNS (the Flexyx Neurotherapy System, a form of biofeedback) treatment for a problem. FNS has been used since 1990 with enough success to warrant respect from former and current patients, as well as from some of the top scientific institutions in the U.S., although controlled studies are only now being performed.

 

Although no significant negative side effects have been observed so far, the ones that we have seen will be listed later; and your understanding of them will help you work with us to provide successful treatment. As with any treatment, you must be comfortable that while the overall record of the use of FNS is quite successful, there can be no guarantee of success in your particular instance. You are therefore invited to consent to be treated on the basis of this information. Before you give your consent to be treated, we want you to read the following and to ask as many questions as are necessary for you to understand this process.

 

 

FNS is not psychotherapy, although the results can sometimes evoke both negative and positive feelings. If you are engaged in counseling or psychotherapy, it will probably be necessary for you to stay in close contact with your therapist.

 

FNS is not a medical treatment and is no substitute for effective standard medical treatment. If you need medical treatment, you are be encouraged to seek it.

If you are taking the following medicines, it will be necessary to stay in close contact with your physician. It has been observed, so far, that the need for these medications often decreases; they remain in your system unused, and people often start having side effects from them because of the decreasing tendency of the body to rely on them. The types of medication are:

 

Ä medicine for sugar problems (diabetes)

Ä medicine for thyroid problems

Ä medicine for migraines and other head aches

Ä medicine for seizure problems

Ä medicine for emotional, thinking, or perceptual problems

Ä medicine for movement problems and spasticity

Ä medicine for low or high blood pressure

 

Anyone who is medically unstable should see ask the therapist to consult your physician before you undertake this process.

 

You will be asked to report any odd or uncomfortable sensations or experiences to the therapist and to your physician.

 

WHAT IS FNS?

 

FNS involves measuring and recording electrical signals from the scalp, and using the frequencies of those signals to guide the speed of a feedback signal from small lights held closely in front of the eyes inside a pair of sun glasses. The lights will usually be so dim that they will not be visible. The recorded signals influence the lights; and the lights, in turn, change the quantity and frequency of the signals.

 

In contrast to other brain wave biofeedback procedures, FNS does not maintain that faster brain waves are better for some problems, or that slower brain waves are better for other problems.

 

Rather, FNS supports the brain waves at rest becoming quieter, and at work, more flexible.

 

The preliminary observations made with FNS have been encouraging enough for us to begin the serious study of potential adverse and beneficial effects. You are being asked for your written consent to participate in this new treatment, and need to consider both the benefits and the risks of doing so.

 

We are looking for:

 

The purpose of this consent is to better describe long and short-term side effects of FNS from our work since 1990. In clinical use, the FNS device has been observed to significantly help ten types of problems:

 

Ä depression

Ä post-traumatic stress disorder symptoms of:

- anxiety

- hypervigilance (or vigilant alertness)

- fears

- anger/rage

- deep sadness

- irritability and restlessness

- feelings of helplessness

- sleeping problems

 

Ä obsession/compulsions

Ä 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

 

Ä spasticity problems caused by stroke and in some cases spinal cord injury

Ä chronic fatigue syndrome

Ä fibromyalgia pain

Ä multiple-personality and other dissociative disorders

Ä attention-deficit and hyperactivity problems

Ä autism in children and young adults

It has been used with approximately 1000 patients with a wide variety of symptoms, and at this time we are closely examining the short- and long-term safety of the procedure.

 

THE FNS PROCEDURE:

 

The brain wave recording process may require the use of a mild abrasive gel or witch hazel to clean the skin. After that some electrode gel or cream will be applied to an ear clip to improve the quality of the recording. A sensor will then be pressed to your forehead or other scalp sites, and held there with a wax paste. A second sensor will be clipped to your ear, as mentioned above. A third sensor will be placed either at the back of your neck or at the base of your thumb.

 

No needles, shocks, skin penetrating, or other invasive procedures are used. The sensor wires will lead to measurement device and then to a computer for analysis. The feedback lights are also connected to the measurement device.

 

During the sessions your eyes will be closed and you will be asked to sit quietly. Most of the time you will either see nothing, or some very dim flickering. Your brain can detect the feedback, although you may not see anything. At other times you may see flashing, which will appear to your closed eyes as patterns of varying brightness, colors, and designs and which look as if they come from differing directions. The speed of the feedback will be controlled by the signals picked up at the scalp.

 

Your only instructions will be to close your eyes, rest, and enjoy the lights. You will not be asked to think of anything in particular, or to learn anything. In fact, you will be asked not to think of any imagery or constructive thoughts which might help you while the lights are flashing: this kind of helpfulness has often slowed the progress of this treatment.

 

You will be frequently asked if you are comfortable with the brightness of the lights in order to adjust them to keep you comfortable, yet interested. This is a passive process.

 

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

 

You will also be asked about your five most prominent symptoms before treatment, and asked to rank order them, from most-to-least prominent.

 

In addition, you will be asked, both before treatment and every few sessions, to complete a questionnaire about your symptoms.

DURATION:

 

You will have as many sessions as you need, each lasting between 6 seconds and 20 minutes duration each session. The rest of the time will be spent as needed talking about what effects, if any, the feedback has had on you. These sessions will occur on a daily basis during the week, or on a weekly basis as convenience dictates.

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

 

1. If your problem came on suddenly after a life of high functioning and you are comfortable with the lights at moderate or higher levels of brightness, you can expect 10 - 20 sessions.

 

2. If your problem came on suddenly after a life of high functioning, and if you are so sensitive to the feedback that the lights need to be severely reduced, you can expect approximately 30 to 40 sessions.

 

3. If you have a lifelong history of multiple problems and are very sensitive to the lights, you may need over 100 sessions.

 

4. In a very few circumstances such as stroke, spinal cord injury, very severe head injury, or genetic physiological disturbances, the number of sessions can easily be in the hundreds of sessions to keep achieving increasing function.

 

RISKS:

 

FLEXYX NEUROTHERAPY SYSTEM (FNS) AND SEIZURES

 

The visual feedback is, most of the time, invisible even in the dark -- although the feedback signal's influence on the signals measured at the scalp is clearly present on the screen of the video monitor. This means that the feedback signals used are many times dimmer than from any other kind of visual feedback system. In practice, there have always been other medical reasons than the use of FNS for the presence of seizures.

 

There have been reported seizures in those who have had prior seizures, generally contributed to by the presence of allergies and inhalant hypersensitivities, asthma, orthostatic hypotension, blood sugar changes, fatigue and overwork, and changes in medication.

 

When a desensitization process is undertaken, the brightness of the feedback signal is increased in to the visible range. However, when this is done properly, this process has always acted as an anticonvulsant and has led to medically supervised decreases in anticonvulsants.

 

One of the biggest sources of seizures is the hasty and medically uncontrolled decrease in anticonvulsants in attempts to decrease their side effects. We do not recommend such decreases, and urge patients to consult their physicians and our therapists about their desires to decrease their medications of any kinds.

 

There is no reason for you to be uncomfortable during this treatment. Your comfort is important. In our experience, people do the best and receive the fastest benefits when they are at their most comfortable during the sessions.

 

Other Potential Concerns:

 

Brief Reactions:

 

There are some potential risks of discomfort involved in participating in this treatment. On the rare occasions when the lights are made brighter, the lights may be too bright, and may make you uncomfortable, irritable, tense, and anxious. This rarely happens for more than a second at a time. When this happens, please tell the investigator and the settings on the equipment can and will be changed to make the lights less intense 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 seven-and-a-half years of experience with FNS and are familiar with many of its benefits and side effects, it is sometimes difficult to know when a feeling, benefit, or problem is due to FNS, 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 FNS. In addition, your own background can play a very big part in the kinds of feelings you have while receiving FNS.

 

Here's a rule of thumb for figuring 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 either to FNS or another physical reason. If, on the other hand, you think you know why your are feeling the way you do, trust yourself.

 

You do not have to know whether something may be due to FNS, 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 FNS treatment:

 

Although the unexpected is always a possibility, we have always found that any side effects that have occurred in FNS 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. FNS 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 FNS treatment, many have never been a fraction of their former intensity, which means that often they have been a lot more manageable than in the past.

 

And while none of these problems have been overwhelming to patients receiving FNS treatment, your comfort is of great importance: so telling us your feelings at any time will help us reduce the side effects and make sure we can best cooperate with your therapist and/or physician.

 

If there is a medical emergency, call us with the particulars, including the location of the emergency room you will be going to, and when; and go there. If the therapist is informed, he or she may be able to meet you at the emergency room. An example of the need for emergency room is to deal with a person who is on a complicated medical regimen, unusually unrelated to their reason for this treatment, and the individual has a medical crisis. It be useful for the emergency room physician to know about this treatment and decide for him or herself whether an adjustment needs to be made in it.

 

Between Sessions:

 

While many people feel energy, ease, clarity, and happiness after an FNS 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 FNS, 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 becoming numb and flat in their emotional responses.

 

Problem Cycles:

Research with FNS has shown that especially long-lived anxiety symptoms correspond with certain complex patterns of signals recordable at the scalp. Although we do have some technology to identify and develop treatment plans with these patterns of brain activity, we do not yet have the technology to easily and efficiently identify them. Therefore relief from some kinds of life-long problems is often uneven, with rises and falls in the level of the problems. 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 less than six have remained the same. The rest have improved. There is no guarantee that you will remain free from these problems cycles.

 

Considerations After Treatment:

It will be time to discontinue FNS when you stabilize and achieve consistently better functioning. You may, however, become used to the stimulation that FNS 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 FNS treatment. During this period your body will become used to being open to its own internal useful stimulation. Most of those who have received FNS have continued to improve long after FNS has ended.

 

BENEFITS:

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

 

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

 

Ä 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 FNS treatment appear to act as rapidly as FNS. Other forms of brainwave biofeedback, also known as EEG biofeedback, are also being used to treat the effects of head injuries. However, EEG biofeedback has also not been subject to controlled studies, appears to take longer, and appears considerably less effective than FNS for problems with mood.

 

PROBLEMS OR QUESTIONS:

 

You may ask questions at any time.

 

 

VOLUNTARY PARTICIPATION:

 

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

 

 

SPONSOR:

 

________________________________, supervises this treatment. He can be reached by telephone at ___-___-_________ or paged at 1-800-___-____________ daily and between the weekday hours of 9 am and 5 p.m.

 

 

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:

Ä under a court order

Ä in case of unlawful behavior such as suspected child abuse

Ä in case you bring legal action against the investigator or the investigator'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 studies 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_________., supervisor, or other staff of the ____________________to use any data collected during the preparation and execution of the FNS 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.

 

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

 

My consent to participate in this treatment is given voluntarily and without coercion.

 

I understand that I may discontinue treatment at any time, and that I may refuse to consent without penalty.

 

________________or other staff of the Center for Neurofunctioning have my permission to contact my physician to both inform him of the circumstances and outcomes of my treatment, and request pertinent medical information about me.

Medication:

 

I am currently taking the following kinds of medications and doses, and have noted what the medications are for and what effects they have on me: (If I am on no medication I will write "none" across all five lines below.)

 

1._____________________________________________________________

 

2._____________________________________________________________

 

3._____________________________________________________________

 

4._____________________________________________________________

 

5._____________________________________________________________

 

I hereby give my consent to _______________. or the staff of the _______________________, to record both benefits and unpleasant effects from FNS.

 

___________________________________

Signature of Prospective Patient or Representative

 

__________________

Date

 

I hereby have read and understood the contents of this Consent document, and consent to receive this treatment and become part of the this treatment.

 

___________________________________

Signature of Prospective Patient or Representative

 

__________________

Date

 

My five most prominent symptoms are: 1._____________________________________________________________

 

2._____________________________________________________________

 

3._____________________________________________________________

 

4._____________________________________________________________

 

5._____________________________________________________________

 

 

_________________________ ____________________________

Signature of Psychologist Signature of Subject or Representative

__________________

Date

 

 

Name:___________________________

 

Age:___________

 

Diagnosis:____________________________________

 

 

I hereby have read and understood the contents of this Consent document, and consent to receive this tereatment.

 

 

_______________________________________

Signature of the Subject or Representative

 

 

 

___________________

Date

 

 

 

 

_____________________________________________

Signature of Treating Therapist

 

 

_________________________

Date

 

 

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