Cranial Electrotherapy Stimulation-CES Therapy Machine

The Drug Overdose epidemic from NY Times.

The Drug Overdose epidemic from NY Times.

AKRON, Ohio — Drug overdose deaths in 2016 most likely exceeded 59,000, the largest annual jump ever recorded in the United States, according to preliminary data compiled by The New York Times.

The death count is the latest consequence of an escalating public health crisis: opioid addiction, now made more deadly by an influx of illicitly manufactured fentanyl and similar drugs. Drug overdoses are now the leading cause of death among Americans under 50.

*Estimate based on preliminary data

Because drug deaths take a long time to certify, the Centers for DiseaseControl and Prevention will not be able to calculate final numbers until December. The Times compiled estimates for 2016 from hundreds of state health departments and county coroners and medical examiners. Together they represent data from states and counties that accounted for 76 percent of overdose deaths in 2015. They are a first look at the extent of the drug overdose epidemic last year, a detailed accounting of a modern plague.

The initial data points to large increases in drug overdose deaths in states along the East Coast, particularly Maryland, Florida, Pennsylvania and Maine. In Ohio, which filed a lawsuit last week accusing five drug companies of abetting the opioid epidemic, we estimate overdose deaths increased by more than 25 percent in 2016.

“Heroin is the devil’s drug, man. It is,” Cliff Parker said, sitting on a bench in Grace Park in Akron. Mr. Parker, 24, graduated from high school not too far from here, in nearby Copley, where he was a multisport athlete. In his senior year, he was a varsity wrestler and earned a scholarship to the University of Akron. Like his friends and teammates, he started using prescription painkillers at parties. It was fun, he said. By the time it stopped being fun, it was too late. Pills soon turned to heroin, and his life began slipping away from him.

Mr. Parker’s story is familiar in the Akron area. From a distance, it would be easy to paint Akron — “Rubber Capital of the World” — as a stereotypical example of Rust Belt decay. But that’s far from a complete picture. While manufacturing jobs have declined and the recovery from the 2008 recession has been slow, unemployment in Summit County, where Akron sits, is roughly in line with the United States as a whole. The Goodyear factories have been retooled into technology centers for research and polymer science. The city has begun to rebuild. But deaths from drug overdose here have skyrocketed.

In 2016, Summit County had 312 drug deaths, according to Gary Guenther, the county medical examiner’s chief investigator — a 46 percent increase from 2015 and more than triple the 99 cases that went through the medical examiner’s office just two years before. There were so many last year, Mr. Guenther said, that on three separate occasions the county had to request refrigerated trailers to store the bodies because they’d run out of space in the morgue.

Early data from 2017 suggests that drug overdose deaths will continue to rise this year. It’s the only aspect of American health, said Dr. Tom Frieden, the former director of the C.D.C., that is getting significantly worse. Over two million Americans are estimated to be dependent on opioids, and an additional 95 million used prescription painkillers in the past year — more than used tobacco. “This epidemic, it’s got no face,” said Chris Eisele, the president of the Warren County Fire Chiefs’ Association and fire chief of Deerfield Township. The Narcotics Anonymous meetings here are populated by lawyers, accountants, young adults and teenagers who described comfortable middle-class upbringings.

Back in Akron, Mr. Parker has been clean for seven months, though he is still living on the streets. The ground of the park is littered with discarded needles, and many among the homeless here are current or former heroin users. Like most recovering from addiction, Mr. Parker needed several tries to get clean — six, by his count. The severity of opioid withdrawal means users rarely get clean unless they are determined and have treatment readily available. “No one wants their family to find them face down with a needle in their arm,” Mr. Parker said. “But no one stops until they’re ready.”

CES Therapy Article from Psychiatric Times 2014

CES Therapy Article from Psychiatric Times 2014

The Rise of Cranial Electrotherapy

Last week, the FDA announced that it plans to approve cranial electrotherapy stimulation, the simple handheld medical device currently cleared to treat depression, anxiety, and insomnia. The FDA “has determined that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices.”1 In short, cranial electrotherapy will soon become the only medical device in the United States that is FDA-approved to treat insomnia and anxiety, and the only home-use device approved to treat depression. As such, it becomes part of the psychiatric armamentarium.

To some, this is jaw-dropping news. But this device has been used in psychiatry practice for years and can be an essential adjunctive treatment to standard modalities of care for soldiers and veterans.

Cranial electrotherapy devices are essentially handheld pulse generators that deliver very low electric outputs. The device generates 1/1000 the output of electroconvulsive therapy (ECT) and connects with sponge electrodes to the side of the head. Patients use the device for 20 minutes twice a day for the first 6 weeks, then less frequently as needed. The device is easy to use and comfortable; it allows patients to go about their morning routine comfortably. The electrical current is gentle (no greater than 4 mA). This is why these devices are often referred to as electroceuticals—not quite as handy as popping a pill, but a lot more convenient than transcranial magnetic stimulation or ECT treatments in doctors’ offices. And cranial electrotherapy causes no serious adverse effects—only a headache or dizziness in fewer than 1 of 250 patients.2

Used as an adjunct to drug therapy and other treatments, cranial electrotherapy is affordable without insurance and easy for patients to use without supervision. The cost ranges from $600 to $800, depending on the manufacturer and features. When used as an adjunct to antidepressants, medication dosages can be adjusted as clinically indicated according to symptoms and adverse effects. Cranial electrotherapy has been shown to attenuate methadone withdrawal and to improve cognitive function in chemically dependent patients.3

The current indication language from the FDA does not specify a diagnosis, but the device is used for the symptomatic treatment of depression, anxiety, and insomnia. This fits with a patient-centered, empirical approach to treatment. This may fly counter to the prevailing DSM-5 culture, but aligns nicely with the realities of many psychiatric practices.

Many of my patients are veterans of the Iraq and Afghanistan conflicts, soldiers who have experienced multiple concussions and suffer from the cumulative symptoms of posttraumatic stress, depression, anxiety, insomnia, and chronic pain. I recommend using the device at home twice a day for 20 minutes at 2 mA. If after 2 weeks there are no changes in symptoms, the current is raised to 4 mA. It is common for sleep to improve after 5 days of twice-daily use. I often see alcohol and drug withdrawal symptoms profoundly diminish after several more days. About 70% of my patients report improvement in their sleep disturbance, anxiety, and depression.

There is published research spanning over 40 years, with at least 20 double-blind placebo-controlled studies that prove benefit outweighs risk.4,5 Several studies suggest that cranial electrotherapy triggers changes in neurotransmitters and endorphin release.6,7

Too many patients do not improve with standard of care. Our nation is facing a mental health crisis in our returning soldiers and veterans. At a time when the VA system is struggling to meet the needs of these patients, I am encouraged that the FDA has recognized that this low-risk technology should be added to our armamentarium.

DISCLOSURES

Dr Xenakis is Brigadier General (Ret), US Army. He reports that he is on the Medical Advisory Board for and Consultant to Fisher Wallace Laboratories.

REFERENCES

1. Kux L. Neurological Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices. June 12, 2014. http://www.gpo.gov/fdsys/pkg/FR-2014-06-12/html/2014-13756.htm. Accessed June 18, 2014.

2. Tadini L, El-Nazer R, Brunoni AR, et al. Cognitive, mood, and electroencephalographic effects of noninvasive cortical stimulation with weak electrical currents. J ECT. 2011;27:134-140.

3. Gomez E, Mikhail AR. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). Br J Psychiatry. 1979;134:111-113.

4. Klawansky S, Yeung A, Berkey C, et al. Meta-analysis of randomized controlled trials of cranial electrostimulation: efficacy in treating selected psychological and physiological conditions. J Nerv Ment Dis. 1995;183:478-484.

5. US Department of Health and Human Services, Food and Drug Administration. Neurological Devices Panel. Statistical review of effectiveness and safety for CES. February 10, 2012. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateria.... Accessed June 18, 2014.

6. YouTube. Dr Xenakis at FDA Hearing for CES. March 26, 2012. http://www.youtube.com/watch?v=dYjq_-HLVz4. Accessed June 18, 2014.

7. Ferdjallah M, Bostick FX Jr, Barr RE. Potential and current density distributions of cranial electrotherapy stimulation (CES) in a four-concentric-spheres model. IEEE Transact Biomed Eng. 1996;43:939-943.