106 La Casa Via, Suite 110
Walnut Creek, CA 94598
This Agreement binds the therapist named ________________ using FNS, and Flexyx, LLC, to terms under which Flexyx Neuroterapy System (FNS) may be used, and under which Flexyx must support the therapist using FNS. Please read this agreement carefully. To maintain a high level of trust between Flexyx and the FDA, any violation of this agreement can mean immediate revocation of the right to use this software, the return of any and all clinical software, and the choice about whether the Associate want to keep the equipment using software from other vendors.
The primary purpose of this agreement is to provide protection for the patient/subject with whom FNS is used. A secondary purpose is to protect the clinician using FNS, and Flexyx, from problems arising from inappropriately selected patients and misapplication of FNS.
Another purpose of the research partnership is to permit clinical research with FNS with the ultimate intention of validating the benefits and limitations of FNS. If the current pilot research and later controlled research demonstrate the safety and efficacy of FNS, it can then be marketed and labeled as helpful with the researched diagnostic problems.
It is intended that Patients/Subjects benefit from the application of FNS, at best, and that no harm come to them, at worst.
It is intended that both Flexyx and the Associate benefit from investigating the use of FNS. The experience gained from the administration of FNS may be shared, in context with both benefits and limits, but with the realization that all data collected and research results are always limited to the particular subpopulation investigated, the particular mix of methods and protocols in use at the time, and that there will always be exceptions to the results observed. Further, it should always be stated that there is no way to tell, in advance, whether particular symptoms will respond to treatment, or at what rate they will respond.
It is not the purpose of the Associatship to provide therapists with a tool that the clinician can represent as useful for the treatment of any medical or psychological condition, or better than any other procedure. It is not the purpose of the Associateship to allow clinicians to promote themselves as using procedures that promise any kind of useful outcome in the treatment of any medical or psychological problem.
Because the data previously collected have been collected under uncontrolled conditions, there is no way to prove claims that it is the FNS process or elements of the FNS process that produce the effects observed.
Associates must be licensed or certified psychotherapists or biofeedback therapists, or those with graduate university training and supervised experience in psychotherapy, who have at least five years of experience, and who work in a practice established for more than two years.
FNS is a either a clinical research tool, or a form of biofeedback and limited to the claims which can be made for any biofeedback technique. FNS is not a treatment for any medical or psychological condition, and must not in any way be offered or represented as a treatment.
It is permissible to share observations made during the use of FNS as observations; however an observation is not a reliable result of the use of FNS with a wide variety of people complaining of any particular problem. The Associate must use the utmost caution to ensure that no presentation about FNS leads a listener to expect reasonable benefits from the use of FNS outside of the diagnostic areas enumerated below.
Head injury and post-concussive problems
Depression, all types from reactive to lifelong endogenous
Stroke and spinal cord injury paralysis (when the home trainer is available)
Post-Traumatic Stress Syndrome
Attention Deficit Disorder, with and without Hyperactivity
Outcome data from the sessions must be copied onto disk and mailed, or transmitted electronically to Flexyx headquarters in Walnut Creek, CA, or entered into the Outcome Database on the Flexyx Web site at least monthly monthly. This data will be analyzed and made availabe to all associates.
Prospective Associates are required to be trained by Flexyx personnel, or those certified by Flexyx as FNS Trainers. No others are permitted to operate the equipment, manage patient/subject problems, or to provide information to the patient/subject on progress.
After Flexyx Introductory and Advanced training, regular data submission, and two years of successful Flexyx-supervised experience, the Associate will be certified by Flexyx as a qualified Associate and Therapist.
Publication of research in a professional peer-reviewed journal will qualify the Associate as a Flexyx Fellow.
Separate Flexyx training is required for the designation of Flexyx FNS Trainer.
The analysis provides evidence of positive and negative effects of the use of FNS, as well as information about its limitations. The analysis also contributes information that both Flexyx and the Associate can use for both scientific and promotional purposes.
The analysis also permits oversight and quality control of the conduct of the treatment/ research, and permits correction of inappropriate protocols.
Associates are able to generate their own daily session reports. Flexyx provides the following reports:
1. Treatment-to-Date reports: In both graphic and tabular form, EEG band activity, dominant frequency, brightness, leading frequency, symptom level, as well as other clinical data over the course of a patient's treatment will be summarized and returned to the therapist.
2. Practice Analyses: In both graphic and tabular form, the above information will be summarized, initially by diagnosis, and later by problems (symptoms), so that the Associate understands the course of treatment by diagnosis, problem, and treatment variables over time.
3. Overall Database Analyses: Provides an examination, across Associates, of neurometric, clinical and therapist factors.
Ways in Which the Analyses are Returned to the Associate
The analyses are initially returned to the Associate in the form of graphs and charts, and later in a number of different forms of research reports, i.e., in written form suitable for publication, and in pamphlet or booklet form, suitable for circulation among professional peers.
Analyses, and excerpts from them, may be used for professional research submission, as well as for community information.
Flexyx has a responsibility to the Food and Drug Administration to insure that FNS carry no safety or efficacy label without research approved by it (the FDA). It is required that all public statements, therefore, be pre-approved by Flexyx to insure that it contains the proper cautions and claims limitations.
Advertisements may mention FNS as a form of biofeedback, neurofeedback, or EEG biofeedback. Mention in pre-approved articles is acceptable. All interviews for publication are to be given only by Flexyx staff, Flexyx Fellows, or Flexyx Trainers, and not by those as-yet uncertified, or by Flexyx Associates/ Clinicians.
While FNS research and results may be reported at professional meetings or to prospective patients/subject by anyone trained by Flexyx, it must be made clear in advance of the presentations that the presentation is not for training purposes unless the presentation is made by a Flexyx staff or Certified Trainer.
Flexyx establishes selection criteria for patients/subjects. Such criteria include patient/subject age, sex, medical condition, psychological condition, and symptom clusters of interest. Patients outside these guidelines may not be studied without prior approval by Flexyx.
Patients/Subjects are to indicate the conditions for satisfaction with this experimental treatment in advance of the treatment, which will provide the criteria for terminating this clinical research with them. Symptom indexes of various kinds, as well as a variety of other paper and pencil, and perhaps neurometric outcome measures must be used to objectify the symptom levels, intensity, frequency, and duration of occurrence. These symptom indexes will clarify the status of the target problems for both patient and Associate.
All patient problem, including rebounds, abreactions, and adverse reactions, are to be documented in writing, recorded into the clinical database, and reported to Flexyx within eight hours of the Associates awareness of them, along with the steps used to manage the problems. There is no exception to this recording and notification.
The purpose of this Associateship is to study FNS. At this state of the research development, the only authorized psychotherapeutic procedures are:
· validation of patient/subject experience,
· deep vascular relaxation for the management of functional vascular pain or psychological abreaction,
· or the provision of perspective, context, and clarification of the process, and what the session events mean for the patient/subject's welfare and progress.
· relaxation techniques,
· other forms of biofeedback,
· and positive self-statements, superliminally or subliminally administered.
Judgment is expected on the part of the Associate to maintain the spirit of the exclusions.
There is an exception to the above rule. The Associate may use his or her clinical judgment to use other procedures if extraordinary circumstances present themselves to maintain the safety of the patient or others. Personal growth or treatment expediency is not an acceptable reason to use other procedures.
This is not a value judgment about the unauthorized procedures. It is only a restriction on the complexity of the treatment administered so that observed effects can be better attributed to FNS, rather than to other treatments.
The Associate must be continuously in the treatment room, or otherwise be responsible for the continuous monitoring of the patient at all times. The patient/subject may move and pull loose an electrode. An electrode may drop off for other reasons. The computer and/or power may malfunction. The patient/subject may suffer a problem related or completely unrelated to the use of FNS.
A trained Flexyx Associate may leave the room if there is present someone trained to observe the patient and the integrity of the process. The Associate may employ an assistant to connect, disconnect, prepare the patient's skin for electrode placement, electrode removal, and skin cleansing. The assistant must be able to retrieve the Associate at any moment if the need arises. The Associate must be available at all times, and not engaged in a parallel treatment.
FNS may be demonstrated, but not used connected to someone without a reasonable history of the patient's problems, and not without the completion by the prospective demonstratee of the Informed Consent it its entirety. If a spontaneously offered history is unremarkable, the prospective demonstratee should be explicitly queried about the presence of thyroid, sugar, convulsive, vascular, psychiatric, head or other central nervous system physical problems including physical and emotional hypersensitivities, and any medication used to treat these problems. A demonstration should not last longer than four minutes of the standard Introductory protocol, regardless of the individual's prior experience with any other form of treatment or sound and light stimulation experience.
While the Associate is expected to avoid the use of excluded therapies, the Associate is explicitly asked to avoid being the patient's/subject's psychotherapist, or trying to simultaneously render psychotherapy and FNS at a session designated as an FNS session. There is not enough time to do both well. It is therefore entirely appropriate for other the Associate to render other "unauthorized" psychotherapies at sessions not designated as an FNS session, or for therapists to be supporting the patient/subject if the need is present. The Associate should freely consult with and refer the patient/subject to an adjunctive therapist if the patient/subject might benefit from such a referral. The need for this possibility is outlined in the Informed Consent; a willingness to be referred out is a pre-condition of inclusion in this process.
All patients/subjects must be interviewed to obtain a history of the problems from which they seek relief. There can be no exceptions to this interview. All prospective patients must be apprised of previously observed treatment results, helpful and unhelpful, as well as limitations of treatment (areas in which it has not worked or worked well).
All informed consents completely initialed and signed by patients/subjects, either the original or a copy, must be sent to the Flexyx office. This allows us to assume responsibility for the conduct of all exploration of the safety and efficacy of the Associate's work with FNS.
The withholding of any one patient/subject's informed consent by an Associate will eliminate the assumption of responsibility of all of the Associate's work, and will become grounds for discontinuance of the Associate's involvement in the research and use of FNS!
Flexyx offers free technical support during the first 30 days after the acquisition of training if Flexyx staff provide and set up the Associate's computer. If the Associate prefers to use and set up his or her own computer, free support after the system is up and running. Otherwise Flexyx staff will charge regular service charges of $120 per hour to set up the Associate's computer.
Technical support fees are associated with practice size, and range between $100 and $300 per month per system. Included in this fee is free software upgrades within the hardware being used, Flexyx home page listing of the Associate on the web site, and two free hours of technical support each month, non-cumulative. This time can be telephone time, or e-mail time. Additional support time may be purchased as needed at the above rate.
Additionally, attendance at web group conferences is available at a fee of $25 per hour.
The per-session fees are charged for two years for any particular Associate.
All research designs are to be submitted to Flexyx for approval prior to the start of the data collection. The purpose of consulting Flexyx at this point is to insure that the designs will actually show what the Associate desires, that the study makes sense clinically, and that the controls are truly controls. Consulting about research design is not considered technical support, and falls outside the time allocations used for technical support.
Once the research design is approved, Flexyx will analyze the data as usual, prepare tables and graphs, and if desired integrate the graphs and tables with the text, and format the bibliographic references.
Flexyx pledges not to alter data or results in any way, or in any other way obstruct the publication of negative results. Negative results from a well-designed and executed study offer useful information to define the limits of FNS.
The data in the database are confidential and are the property of Flexyx. They are the basis for the design and advancement of the software. However all the data that forms the basis for an experiment for publication, and the analyses based on those data, are open for independent review and auditing by governmental, educational, and scientific bodies who are authorized to conduct such review and independent analysis.
All public statements, verbal, electronic, printed, video, and graphic, must be submitted for approval to Flexyx. This is to insure the accuracy and contextualization of any public statements.
Training may only be done by Flexyx and those certified by Flexyx as Certified Trainers. This is to insure that the treatment and treatment protocols are current.
Only the individual(s) designated by Flexyx as an Associate may conduct treatment with FNS, which includes monitoring and testing the integrity of the electrode connections as well as all other connections in the system, monitoring of the appropriateness of the settings of the system during its administration, and providing the designated permissible psychotherapeutic support during the sessions. All protocol changes, including feedback intensity and modifications to session length, are to be made by the Associate.
Involvements by other staff in the treatment may occur in the attachment and detachment of electrodes, preparation and cleaning of the patient/subject's skin.
Each Associate must carry professional liability insurance covering errors and omissions, and send a copy of the policy notice to Flexyx.
The Associate is entitled to use the FNS system for thirty days without charge to enhance familiarization and comfort with the system. All telephone consultation is offered without charge during this period. If the clinician is unhappy with the system or any aspect with its use during the initial 30 days, the hardware and software may be returned for a full refund. There is no refund for the training.
If the Associate is dissatisfied for any reason during the second and third months after training, any or all of the hardware may be returned if it is good working order and cosmetically clean and undamaged. But all of the FNS software (including original and upgrade disks) must be returned.
The Associate's money for the hardware and software will be refunded, less $2167 per month for the time in use before notification of termination. The use of the equipment during this period will be considered a short-term lease in this case.
If the Associate wishes to keep any of the equipment, the amount refunded will reflect the value of the equipment the Associate wishes to keep.
No refunds will be granted after the initial three months.
The discovery of the failure to comply with any of the terms or conditions of this agreement will begin the process of remedying the compliance failure. If attempts fail to remedy the problem, a report may be made to the enforcement section of the FDA as well as to any funding sources for the research undertaken by the Associate, if relevant. If independent findings confirm violation of the agreement, the Associate agreement will be terminated, as will be continued involvement in the research. At this time all FNS software is to be returned and further use of the FNS software is forbidden. Any certification process(es) will terminate. There will be no refunds of any kind under these circumstances. The Associate will be liable for all collection and repossession charges, including court and legal fees.
The Associate may be entitled by law to protections both excluded, and not enumerated here. This agreement will in no way supersede state or federal laws. Any provisions of this agreement found to be invalid by law will not affect the force of the remaining provisions.
I have read the above provisions, have had my questions answered, understand the provisions, and agree to abide by them.
Len Ochs, Manager, Flexyx, LLC Date