Response to the FDA's Proposed Rule

Nation-wide support for re-classification...

Issue #6

 

If the FDA takes action which will reduce or eliminate patient’s access to this device, many patients will suffer needlessly and will be forced to return to dependence on analgesic, anxiolytic, or antidepressant medications.

- Dr. Harbin (excerpt from letter)

Recently the FDA published a Proposed Rule in the Federal Register regarding cranial electrotherapy stimulation (CES) and opened a 90 day public comment period on CES. This rule would require Pre-Market Approval (PMA) for CES, while for the past 30 years CES devices have been legally cleared to market in the USA by the FDA.  At the end of this comment period the FDA will issue a final rule which will either down classify CES to Class II or will call for all CES manufacturers to prepare PMA Applications.  To view the FDA docket including proposed rule, please click here.  

Approved for over the counter sales in Europe, China and Canada, the Alpha-Stim devices have gone through an extensive review process for the FDA six times since 1981 and have been cleared to market.

The response we received in support of down-classification is astounding! We would like to take this opportunity to share some of the letters with you.  These doctors, patients, chaplains, and military personnel have great stories about the results they have received from using the Alpha-Stim in their practices and at home.  

Please review some of these astounding letters, so you can see why we are energized to continue the "good fight" and explain what a valuable tool Alpha-Stim is for practitioners.

COL Platoni's Letter

Ms. Ehrlich's Letter

Chaplain Fair's Letter

Fr. Mangoian's Letter

MAJ Hutchison's Letter

Dr. Harbin's Letter

Dr. Eidelman's Letter

Dr. Nichols' Letter

Dr. Dereberry's Letter

Dr. Overcash's Letter

EPI’s Response

 

The Military and Alpha-Stim...

We are pleased to have new survey data from the military.  Military Personnel Survey Analysis Summary, written by Larry Price, PhD., is a must read and a great breakdown of the effectiveness of Alpha-Stim among our different indications with or without medication. Click Here for the full version of the survey.

SPECT Brain Imaging

S.P.E.C.T Brain Imagining 

Issue #5

At the American Association of Christian Counselors (AACC http://www.aacc.net/) conference in September, Begin Healing shared the exhibit hall with the SPECT Brain Imaging booth run by The Clements Clinic.  Dr. Todd Clements found some time to sit down with us and talk about his practice and how he has incorporated the Alpha-Stim.

SPECT (Single Photon Emission Computed Tomography) Imaging is a nuclear brain scanning technique developed by Dr. Amen, MD (author of Change Your Brain, Change Your Body).  Dr. Todd Clements, MD, joined the Amen Clinics in 2006 where he trained in SPECT Imaging.  In 2008 he became Medical Director of Clements Clinic, his own out-patient psychiatric practice in Plano, Texas, which specializes in the SPECT scan.

A SPECT scan is performed by injecting a very small dose of a radioactively tagged compound (Ceretec) that is taken up by the brain.  Once in the brain the Ceretec emits energy for the next few hours.  The cameras in the SPECT scanner slowly rotate around your head and detect this energy in the form of light.  The most active brain cells will emit the most energy and the least active ones will emit the least energy.

Whereas MRI and CT scans look at the structure of the brain, SPECT looks at the functioning of the brain in terms of cerebral blood flow and activity patterns.  With these 3D images they are able to evaluate 1) areas of the brain that work well (2) areas of the brain that work too hard and (3) areas of the brain that do not work hard enough. Among other reasons, this is helpful because there are many cases where the brain’s structure is normal, but the way it is functioning is abnormal.  

Brain with ADD before treatment

Brain with ADD after treatment

The Clements Clinic website helps explain this difference with an analogy: “If you were flying in an airplane today you would want to know that the engine was working right.  Taking a picture of the engine (CT/MRI) shows you all of the parts, but does not give you any information about how well the engine is running (functioning).  A brain SPECT image identifies important information about your brain’s functioning.  Identifying areas of abnormal functioning can be vitally important in helping you doctor make the best diagnosis and treatment plan for you.”

When asked about how he generally uses the Alpha-Stim in his practice, Dr. Clements said he usually uses it with teens, and for patients with sleep, anxiety, or anger problems.   First, the patient comes in for a SPECT scan, and if their brain shows over-activity in the basal ganglia or in the thalamus, then the patient is a likely candidate Alpha-Stim treatments. 

“Instead of taking a Xanex when they feel anxious,” said Dr. Clements, “they can do a 20 minute session with the Alpha-Stim. I find it’s a good tool. A lot of people come in on benzos or clonazepam. These people just get used to popping [a pill] when they get anxious, so I find it’s a good alternative for these drugs.”

He has also found that the Alpha-Stim helps chronic marijuana users feel less anxious when they stop using.  Such cases are examples of patients that show over-activity in the thalamus in their SPECT scans. Dr. Clements also pointed out that when patients dealing with addictions can actually see how their substance abuse is effecting the brain, they are more likely feel motivated to change their behavior.

Along with evaluating the specific brain patterns associated with mood disorders, the SPECT Imaging can also evaluate memory loss, the effects of brain trauma, aggressive and/or violent behavior, cerebral cardiovascular disease, the extent of impairment that drugs, alcohol and other toxins have done to the brain.

Perhaps the most important aspect of the SPECT technologies is that a scan can help determine the type of ADD, anxiety, or depression that is present. Far too often are people diagnosed with ADD and immediately prescribed a stimulant, when their type of ADD could be treated more effectively with multivitamins, fish oil supplements, and/or CES.  The more we know about a persons specific condition or type, the better we will be at treating them.