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- Biofeedback Industry and FDA Compliance: Dr. Anand Akerkar, Ph.D.
- Chief Executive Officer mdi Consultants, Inc. , 55 Northern Blvd. , Great Neck, NY 11021 Tel# (516) 482-9001 Fax# (516) 482-0186
- E-Mail Anand@mdiconsultants.com website: www.mdiconsultants.com
- For decades, industries such as pharmaceuticals, diagnostics, biologicals, dental etc. have been complying with the FDA regulations and striving. Biofeedback falls into the category of both diagnostics and treatment which has always been found to be both safe and effective. However, the FDA has always felt that biofeedback is not a science, and is probably more like "witchcraft". This statement is not meant to underscore the FDA’s understanding of the subject, but it is a reflection on the attempts that the biofeedback industry has made to gain the scientific recognition it deserves. However, more recently FDA has begun to accept biofeedback as a recognized technique for diagnostic uses.
By complying with FDA regulations including the GMP, filing properly prepared 510(k)s, and/or PMAs, this will certainly help this industry to be in par with the other industries burdened with these same FDA regulations. This presentation will focus on how to comply with FDA in a proactive approach, its pros and cons and the problem if one fails to comply.
- Five years of Neurofeedback in a Public Charter School - Building a Base and Expanding into the Community. John S. Anderson, MA
- A Chance To Grow, Inc./New Visions School - IDS #4011 3820 Emerson Ave. N , Minneapolis, MN 55412 612-521-2266 e-mail - firstname.lastname@example.org
- Report on 34 elementary school students receiving daily AVS training
- Twenty public and fourteen parochial school students received daily Audio/Visual Stimulation (AVS) training in Perham, a small community in northern Minnesota. Pre-testing consisted of the TOVA 7 and teachers and parents completion of the Burks’ Behavior Rating Scale (Burks’). Eight of the students were given more extensive academic testing pre and post training. Students were referred to the program with a variety of learning and behavior problems including attention problems, impulsivity and hyperactivity, reading and other academic delays, anxiety and others.
- Parent permission was obtained using a carefully developed informed consent, which documented the potential negative effects, including the possibility of induced seizure activity from the training. Students received an average of 31 sessions of AVS training with a minimum of 26 and a maximum of 35 sessions out of 38 opportunities. Equipment used was the Comptronics David Paradise XL unit amplified through a 10 person splitter with individual sound and light intensity controls for each participant. "Tru-View" eyesets with white lights were used throughout the study.
- Sessions lasted 20 to 22 minutes. The first 8 sessions consisted of a combination of alpha and theta frequencies. Subsequent sessions utilized a protocol developed by Michael Joyce consisting of cycles of 2 minutes with left brain (right visual field and right ear) stimulation at 18 hz and right brain (left visual field and left ear) stimulation at 12 hz followed by a 30 second ramp to 10 hz bilaterally for 2 minutes and then a repeat of the cycle for 22 minutes. All sessions finished with a 1 minute "soft off" period.
- Results are currently being evaluated and will be presented for the first time at the Futurehealth Conference in Palm Springs. Preliminary results show significant improvement in most measures.
Schools and Clinical Practice - Neurofeedback is not enough. John S. Anderson
- Five years of Neurofeedback (NFB) in the public schools and in clinical practice shows that EEG is not enough. This workshop will present data on more than 100 students plus specific case histories. It will also challenge your assumptions with data on AVS, HSAS, VT, and NPP which address needs that NFB cannot. These methods can be an exciting adjunct to a clinical practice.
- Abstract: Five years of experience using NFB in the public schools and in clinical practice has shown that NFB alone is not sufficient to address all the needs presented by students in the school or by clients in a clinical practice. Other interventions may be more effective and may be necessary before NFB can work. Screening or testing for theses needs and then providing training specific to their resolution can significantly enhance a private practice. It is also a highly effective approach to the difficulties faced by our public and private schools.
- Neurofeedback training was introduced to the Minneapolis Public Schools in 1990. Housed in Shingle Creek School in North Minneapolis, the program saw only a few students but results were encouraging so the program continued. The program moved to Harrison School in 1991 and then found a permanent home in New Visions School in 1992. New Visions School also incorporated other unique educational interventions such as Vision Therapy (VT) and Neuro-Physiological Programming (NPP). It became clear that these interventions were effective for students when NFB was not or was a helpful adjunct to NFB when this was indicated.
- Students who could not perform basic visual processing tasks needed specific visual training exercises to encourage the development of appropriate visual processing skills. Children with poorly developed nervous systems who had mixed hand, foot, and eye dominance needed specific physical exercises repeated daily with sufficient frequency, intensity and duration to encourage age appropriate neurological development.
- These services were grouped loosely under the umbrella of a non-profit agency known as A Chance To Grow, Inc. (ACTG). New Visions School (NVS) was a Public Charter Elementary School begun by ACTG to provide a way to bring these services to underserved children and adults in the inner city of Minneapolis. The gains realized by NVS students were remarkable. Starting with at least a year deficit in reading to be enrolled in NVS, students have made an average of 1.6 years gain in reading level for each year NVS has been in operation. Where they were failing in their previous school placement and falling further and further behind in reading each year, now they were making more than a years gain for each year they were in NVS.
- The services were also available to adults and children from the surrounding community both during the school year and through intensive summer programs. Results for these outside clients were equally impressive and encouraged ACTG to begin the process of raising funds to build an new building to more adequately house all of its programs.
- In 1996 the Speech and Audiology department of ACTG began exploring the use of corrective measures for students with auditory processing deficits. They settled on a standard program developed by Kjeld Johansen of Denmark which uses specifically designed audiotapes to promote optimal hearing levels and right ear dominance. The first year only 10 students received this training and only 7 received pre and post testing. Of these, 6 improved and 4 showed significant improvements.
- Audio/Visual Stimulation (AVS) was introduced on a limited basis in the fall of 1997. Michael Joyce, an associate of ACTG in Perham Minnesota, began a more comprehensive program at the same time. He performed pre and post TOVA’s and parent and teacher Burks’ Behavior Rating Scales with 34 students who received daily AVS sessions focused on increasing mental flexibility. Results were generally quite positive and in some cases were remarkable.
- This workshop will present ways clinicians can incorporate these methods into a private clinical practice and will also cover how to bring these methods into the public and private schools in virtually any area.
- Sources of funding will be discussed including state grants for technology, special education services and demonstration projects.
Treating Depression with the Asymmetry Protocol: Progress and Problems Elsa Baehr, Ph.D.
- Clinical Associate, Dept. of Behavorial Sciences, Northwestern University and Private Practice, Evanston, Il.
- Baehr & Baehr LTD. 1603 Orrington Avenue, Evanston, IL 60201 (708)869-2853 (708)676-1779 fax: (708)869-8070 email: email@example.com
- For the past three years we have been using an alpha asymmetry protocol* as an adjunctive treatment for clinical depression. While we have seen apparently remarkable change in a short time in some individuals, we have found that this treatment approach does not work for all types of individuals, and all types of depressions. This paper summarizes our current findings, and discusses some of the problems which have emerged during the treatment process.
- *A patented protocol. Dr. Peter Rosenfeld, Dept. of Psychology Northwestern University Evanston, Il. firstname.lastname@example.org
Combining QEEG and Evoked Potentials for the Classification of Various Psychiatric Behaviors: Toward Improved Differential Diagnosis Donald Bars, Ph.D.; F. LaMarr Heyrend, MD; C. Dene Simpson, PhD; & James C. Munger, PhD
- Donald Bars, Ph.D Treasure Valley NeuroScience Center 411 North Allumbaugh Boise, Idaho 83710
- (208)376-2518 fax# (208)376-2521 e-mail# email@example.com
- This paper discusses the results of an on-going quasi-experimental research project investigating the use of quantitative electronencephalographic (QEEG), visual (VEP), and auditory (AEP) evoked potential studies as aids in the differential diagnosis of psychiatric behaviors in children and adolescents. Participants were 328 individuals (ages 6-18) evaluated during 1995 and 1996. Based upon preliminary clinical research in our laboratory, individuals were classified into four groups, (1) Attention/Deficit- Hyperactivity Disorder (ADHD), (2) Affective disorder without VEP indicators of explosive or ruminating behaviors, (3) Affective disorder with VEP indicators of explosive or ruminating behaviors, and (4) mixed ADHD/affective disorder (N=42, 83, 118, 85 respectively).
- Statistical analysis of QEEG absolute power, across all standard revealed that each group could be significantly (all p’s < .001) distinguished by the activity occurring. The outcome of this study suggests that it is possible to utilize electrophysiological data to obtain more precise diagnostic categories associated with ADHD and affective disorders, enhancing therapeutic specificity and outcomes.
- Neurofeedback with Court Ordered Criminal Offenders In & Out of Jail, Alfonso Bermea
- Neurotherapy Consultative Services 2467 SW Kingsrow Road Topeka, Kansas 66614 firstname.lastname@example.org
- Alfonso will present current information on the treatment of clients who have been convicted of driving under the influence of alcohol (DUI) or convicted of possession of illegal narcotics and those who were drinking when they committed domestic violence and are court ordered to attend and complete drug and alcohol treatment. The information he will share describes a new relationship between Neurofeedback and the criminal justice system. At a time when the courts are searching for an effective alternative to incarceration and recidivism this model of treatment offers much hope.
Workshop Applying Neurofeedback to Criminal Offenders: Alfonso Bermea
- Anyone working with clients who have a history of problems which led to involvement in the criminal justice system will appreciate the information Alfonso will present in this 2 hour workshop. Alfonso will cover the clinical treatment of addictions, alcoholism, drug addiction, post traumatic stress disorder, mild closed head injury, ADD, ADHD, violent behavior, and domestic violence. The issue of interfacing treatment with the court system and developing referrals will be covered. Alfonso will report on the status of Neurofeedback in the criminal justice system focusing on the development of a new model of treatment incorporating Neurofeedback as the foundation for change
- Bio: Mr. Alfonso Bermea Jr. currently lives in Topeka, Kansas where he serves as the Program Coordinator, for the Wellness Addiction Community Treatment Health (WATCH) program. This program is directed by the Life Sciences Institute of Mind Body Health, Inc. under the directors Steve Fahrion, Pat Norris, Carol Snarr and Jeff Nichols all formerly of the Menninger Institute in Topeka. Alfonso's experience in working with violent, addicted criminal and psychiatric populations spans more than decade. Alfonso is recognized for the research he conducted while with the Texas Youth Commission, working with violent and addicted youthful offenders who had committed murder.
- Alfonso is the Chief Executive Officer of Neurotherapy Consultative Services a private company he developed to provide training and consultation nationally and internationally.
Fundamentals of Neurofeedback: The Five Phase Model of CNS Functional Transformation (For the Foundations Course) Valdeane Brown
- 121 Prospect St. Port Jefferson NY 11777 516-473-7317 email@example.com
- Neurofeedback is a breakthrough approach to resolving dysfunction, improving performance and enhancing life experience. However, most of the models and techniques are overly complex and confusing to beginning practitioners. This presentation discusses a simple, yet comprehensive approach to Neurofeedback that integrates all of the other major protocols. Utilizing a Five Phase Model, this core approach gives you a firm functional understanding to how the CNS recovers from dysfunction and returns to its natural state of healthy chaos. From this perspective it becomes possible to understand the underlying core of the clinical practice of Neurofeedback in a way that will simplify the learning process and let you get results quickly – regardless of what brand of equipment you use.
- You will learn:
- -How "theta" is actually composed of three targets frequencies (3, 5 & 7 Hz) each with its own role in health and dysfunction
- -To target augment frequencies precisely and sequentially to treat even the most challenging clients in a safe manner
- -The differential effects of training Alpha (8-12 Hz), SMR (12-15 Hz), Low Beta (15-18 Hz), Aura (19-23 Hz), Peripheral Warmth (26-30 Hz)
- and Shear (38-42 Hz) Rhythms
- -The use of FFT and direct digital filtering systems and their relative roles in clinical decision making and data analysis
- -The value of Cz as a central site for training
What you don’t know about NF could fill a book – or empty your Practice Part I: The Period 3 Approach to the Chaotic Control Mechanisms Underlying CNS Renormalization Valdeane Brown
- Neurofeedback is an exciting arena in which new discoveries and protocols are emerging at an unprecedented rate. The list of disorders and conditions that respond to Neurofeedback is almost as extensive as the bewildering array of techniques and theories that have promulgated around it.
- The field is limited, however, by linear models of EEG and overly complex neuroanatomical theories. These older ideas have led clinicians to maintain a "sickness" based orientation that is predicated upon discerning the precise disorder afflicting each client and, then, devising a specific treatment for that particular disorder. At best, such linear complexity is unnecessary for developing an effective paradigm for neurofeedback.
- Most of the clinical applications of Neurofeedback have used a single channel of EEG, with multiple bandwidth filters being applied, in order to provide feedback re: ongoing shifts in frequency and amplitude in the EEG signal. These approaches are based on linear mathematical models which assume a one-to-one relationship between feedback targets and clinical change. Thus, for example, an increase in amplitude in a particular frequency range (Beta) is thought to lead to a decrease in a specific symptom (Early Morning Awakening). Although these theories have expanded to include simultaneous inhibits of different bands and to the use of ratios between the inhibit and augment targets (e.g. Theta/Beta ratios and ADD, they remain unidimensional, linear, neuroanatomically anchored and symptom oriented. They have also led to protocols using only minimal sets of auditory and visual feedback in order to keep from "overwhelming the client" with too much information.
- These traditional approaches ignore two critical factors: a.) the EEG signal is non-linear, dynamical, chaotic in structure; andb.). the CNS is non-linear in organization. Four important elements emerge from a close consideration of the non-linearity of the CNS and EEG.
- 1. EEG is not appropriately captured by mathematical tools based on linear transforms (such as FIR, IIR, FFT or even IQM techniques).
- 2. Dysfunction is better characterized in terms of discrete attractors within the spectrum, and functionality is better captured as the ability to fluidly shift amplitudes throughout the spectrum.
- 3. The CNS can not be trained optimally with linear procedures, but requires the use of non-linear, dynamical control mechanisms.
- 4. Since the CNS is non-linear, it is designed to process and respond effectively to incredibly dense stimuli arrays in the midst of very noisy environments so feedback can be complex, differential, syncopated and simultaneous.
- This presentation demonstrates and discusses a radically different approach to Neurofeedback that integrates these ideas and addresses the problems inherent in the older, linear models. The Period 3 Approach trains multiple feedback parameters simultaneously using two discrete, real-time channels of EEG. Unique non-linear, dynamical approaches to threshold setting are utilized in very precise ways that reflect the chaotic structure of the EEG itself. Combining these factors appropriately challenges each hemisphere to disrupt its specific attractors of dysfunction while being chaotically synchronized to basins of functional stability. This directly perturbs the entire CNS to maximally reorganize its dynamical structure and reestablish a healthy degree of chaos – i.e., the adaptive and resilient chaos that is characteristic of vital physiological systems. The goal is to increase the self-regulatory ability of the CNS, not to decrease particular symptoms, so a single, comprehensive theory can be applied effectively to all clinical phenomena -- regardless of the presenting complaint or emergent symptomatology of the client.
What you don’t know about NF could fill a book – or empty your Practice Part II: Clinical Nitty-Gritty of the Period 3 Approach see Sue Dermit
4 hour workshop: Using Non-Linear, Dynamical Control Mechanisms to Simplify and Amplify the Power of Neurofeedback: Moving From the Five Phases to the Period 3 Approach: Valdeane Brown
- Clinical approaches to Neurofeedback are often highly detailed and complex, leading the beginning- and even experienced practitioner, to feel less than adequate in treating the variety of disorders that walk through the clinical door.
- Such complex treatment protocols stem from a viewpoint which places disorder at the hub of our interventions- a "sickness based" model which, much like western medicine, assumes disorders are discrete entities necessitating different and distinct treatment protocols. Under this model, the challenge is to discover the "right" treatment, which is also likely to be "wrong" for another disorder.
- The powerful yet simple strategies to be offered in this "hands-on" presentation stem from a way of working that places self-regulation, not disorder, at its center. We call this paradigm the Period 3 Approach.
- This new approach integrates non-linear, dynamical approaches to control of feedback systems with the clinical wisdom of the prior Five Phase Model of CNS Functional Transformation developed by Dr. Valdeane W. Brown.
- The Period 3 Approach trains multiple feedback parameters simultaneously using two discrete, real-time channels of EEG. Unique non-linear,
- dynamical approaches to threshold setting are utilized in very precise ways that reflect the chaotic structure of the EEG itself. Vital to the
- safety and success of this approach is the use of appropriate inhibits.
- These will be detailed as well as sequences of augments. The extraordinary non-linear results currently noted from the use of an original (21 Hz), and a less commonly used (40 Hz), frequency bands will particularly be addressed, as will working with patients concurrently receiving ECT. You will also discover how you train two very different attentional states on the left and right side of the brain simultaneously, increasing the power of your interventions.
- Combining these factors appropriately challenges each hemisphere to disrupt its specific attractors of dysfunction while being chaotically synchronized to basins of functional stability. This directly perturbs the entire CNS to maximally reorganize its dynamical structure and reestablish a healthy degree of chaos – i.e., the adaptive and resilient chaos that is characteristic of vital physiological systems. The goal is to increase the self-regulatory ability of the CNS, not to decrease particular symptoms, so a single, comprehensive theory can be applied effectively to all clinical phenomena -- regardless of the presenting complaint or emergent symptomatology of the client.
- Neurofeedback is unparalleled as a vehicle for providing the brain with what it works with best- information. Given appropriate information the brain begins to self-regulate more effectively and efficiently. When this happens, a myriad of apparently disparate symptoms drop away. It doesn’t matter if you are talking about anxiety, depression, immune system dysfunction or pain- it is, after all, all the same nervous system.
- The Period 3 Approach is equally applicable to remediation of symptoms as well as training for personal growth, spiritual development and optimal (peak) performance. Its simple and straightforward methods will particularly resonate with:
- __ providers interested in appealing to the "personal growth" market as a means of reducing dependency on managed care;
- __ providers who want to ensure rapid and powerful results while effectively eliminating unwanted side effects;
- __providers challenged by a particularly diverse range of client problems, and
- __ entry level Neurofeedback practitioners who are excited but confused about how best to proceed with development of their own clinical practice.