Is neurofeedback experimental?
Many insurance companies and health professionals describe any treatment that does not have specific approval by the FDA or as experimental. As far as we can tell, that's the only definition. For a wonderful discussion of the subject of off-label vs. experimental, click here.
So is neurofeedback experimental? Well, it's not approved by the FDA to be used for the treatment of depression or anxiety or ADD, three common clinical uses. So does that make it experimental?
EEG neurofeedback equipment is regulated by the FDA. If a manufacturer registers it with the FDA (not all do), they are registering it as a medical device. Under FDA guidelines, these devices can be used for "stress reduction" by licensed health providers. That's a label required by the FDA.
So any licensed clinician can use that tool as they see fit, in what is called "off-label" use. MD's of course prescribe a large number of medications based on off-label use. For example, it is common practice for many medications to be provided to children that have never been tested in children.
"From a legal and ethical standpoint, off-label use represents a delicate balance between the regulatory objective of protecting patients from unsafe or ineffective drugs and medical devices on the one hand, and, on the other hand, the prerogative of physicians to use their professional judgment in treating patients."
Maxwell J. Mehlman, J.D., Director of the Law-Medicine Center,
Case Western Reserve University School of Law.
The FDA doesn't regulate what clinicians do. They allow clinicians to use whatever tools or techniques they deem fit to help clients as long as it fits under their scope of practice (excuse any over-simplifications).
"Because the pace of medical discovery runs ahead of the FDA's regulatory machinery, the off-label use of some drugs is frequently considered to be 'state-of-the-art' treatment. "In some circumstances, an off-label use of a particular drug or device may even define the standard of care." Tennessee appellate court observed in Richardson v. Miller, 44 S.W.3d 1, 13, n.11 (Tenn. Ct. App. 2000):
In our FAQ, we explain the most common practices of a growing number of licensed health providers. It is a an accumulation of clinical use from hundreds of clinicians over 20 years of clinical experience with thousands of patients. Most clinicians use neurofeedback as an adjunct modality to other therapies. There's 30 years of research backing up neurofeedback Also, a lot of neuroscience research and research into EEG mechanisms, arousal mechanisms from the reticular activating system and thalamo-cortical loops all relate and support the work of neurofeedback.
At the American Psychiatric Association annual meeting, common clinical practices have been discussed for the last 4 years. The research is solid. These common practices have been discussed at conferences for 20+ years, by MD's, psychologists, Licensed Social workers and other health providers. There is a large amount of studies and literature and studies that support these common practices.
Someone suggesting neurofeedback is experimental perhaps means they think it's inappropriate for health professionals to use neurofeedback for off-label uses. If that's true, neurofeedback providers share good company with large number of MD's who've done it for years.
Off-label use is an issue that crosses all modalities. Neurofeedback is just one. As an example, for many years (thousands), acupuncture was used for chronic pain. But in the US, it was experimental because the FDA had not approved it. MD's were being trained at UCLA long before it was approved. It only was approved after large multi-million dollar studies were finally done. It took many years of lobbying to get funding. In general, large capital won't fund large studies that use "non-proprietary" tools or techniques.
However, unlike acupuncture, EEG neurofeedback devices are already under FDA, so the devices can NEVER be called experimental.