Stephen N. Xenakis, MD

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.”

 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.

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.

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.

Several studies suggest that cranial electrotherapy triggers changes in neurotransmitters and endorphin release.

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.

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.

 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.

 Tadini L, El-Nazer R, Brunoni AR, et al. Cognitive, mood, and electroencephalographic effects of noninvasive cortical stimulation with weak electrical currents. 

 Gomez E, Mikhail AR. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). 

 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. 

 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/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM296891.pdf. Accessed June 18, 2014.

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

 Ferdjallah M, Bostick FX Jr, Barr RE. Potential and current density distributions of cranial electrotherapy stimulation (CES) in a four-concentric-spheres model. 

Articles

Cranial electrotherapy devices, soon to be only home-use device approved to treat depression, can be an essential adjunctive treatment to standard modalities of care for soldiers and veterans, says this psychiatrist.

The Rise of Cranial Electrotherapy

In 2004, the news that Americans had committed abuse and mistreatment in Abu Ghraib and Guantanamo was shocking. Even more alarming were the revelations that physicians, psychiatrists, and other mental health professionals had assisted with interrogations that bordered on torture.

In the span of just 2 generations, the United States had drifted from condemning Nazi physicians at the Nuremberg Trials for their collusion with torture, in­human experimentation, and cruel mistreatment to justifying waterboarding in the pursuit of better intelligence.

As a retired brigadier general and Army psychiatrist, committed to a strong military and national defense, I find these scandals to be most disturbing. The complicity of psychiatrists and other physicians clearly deviated from the fundamental ethical principles of the medical profession and military medicine. My generation of soldiers, who had served during the Vietnam War, vowed not to repeat the misdeeds of the My Lai massacre and rampant indiscipline we witnessed.

But after the attack on the World Trade Towers, fear and anger dominated the country’s emotional climate and the principles of our profession were hijacked. The incessant drumbeat of political rhetoric that “the war on terror is a war like no other” and that “we must take all measures possible to stop the enemy” made it somehow easier for psychiatrists to apply their skills and training to exploit the vulnerabilities of prisoners. To this day, former government officials justify cruel and inhuman treatment of detainees at Bagram and Guantanamo with unsubstantiated assertions that their confessions led to the trail of Osama bin Laden.

The public supported such conduct, and the television show 

 gained wide popularity as viewers were captivated by threats of violence and new gimmicks for bringing the bad guys down. Even the presidential candidates in 2008 were ambushed by questions that judged their fitness to be Commander in Chief by their willingness to torture a suspect who planted a “ticking bomb.” But there is no evidence to confirm the assertions that torture of prisoners has helped the war effort at all.

The plain fact is that nothing that has been claimed in the name of defending our country can justify cruel, inhuman, and degrading treatment of another man or woman. Torture, in any form-light or heavy-is not a tool of interrogation or useful for gathering good intelligence. It is a propaganda tool, and it degrades the perpetrator as well as the victim. This is not just the rhetoric of bleeding heart progressives. It is the opinion of more than 50 retired admirals, generals, and senior government officials convened by Human Rights First to discuss this issue, and our conclusions can be stated simply:

General George Washington laid down the directive that American soldiers will treat the enemy humanely and conform to high moral and ethical principles on the battlefield.

Experienced interrogators acknowledge that information extracted by the use of torture is unreliable.

Veteran FBI and military interrogators have spoken out publicly against the use of physical pressure in interrogation.

 “. . . a person who is tortured is damaged, but so are the torturer, the nation, and the military.”

Torture has long been associated with political repression and with regimes without any semblance of an independent judiciary or media. The Soviet Union’s imprisonment of dissenters and forced use of psychotropic medication on them, the Khmer Rouge’s torture of thousands of people in Cambodia, and the Augusto Pinochet regime’s brutality against prisoners in Chile all bear witness to the association between totalitar­ian or authoritarian regimes and their use of torture.

The human rights lawyer Leonard Rubenstein and I wrote in March 2010

The medical staff at the CIA and the Pentagon played a critical role in developing and carrying out torture procedures. Psychologists and at least one doctor designed or recommended coercive interrogation methods including sleep deprivation, stress positions, isolation, and waterboarding. The military’s Behavioral Science Consultation Teams evaluated detainees, consulted their medical records to ascertain vulnerabilities and advised interrogators when to push harder for intelligence information. Psychologists designed a program for new arrivals at Guantnamo that kept them in iso­lation to “enhance and exploit” both their “disorientation and disorganization.”

Medical officials monitored interrogations and ordered medical interventions so they could continue even when the detainee was in obvious distress. In one case, an interrogation log obtained by 

magazine shows a medical corps-man ordered intravenous fluids to be administered to a dehydrated detainee even as loud music was played to deprive him of sleep.

We cannot dismiss the psychiatrists who participated in interrogations in Guantanamo and the mental health professionals who helped devise the abusive practices as mere rogues or outliers. They were actors on a much larger stage. They were swept up by a pervasive and persuasive attitude that subsumed the country and energized a military plan to “hunt down the criminals wherever they may be hiding.” The Department of Defense issued policy accordingly, and the Office of the Assistant Secretary for Health Affairs contended that the legitimate objective of fighting terrorism trumps the ethical responsibility of the healing practitioner. In their eyes, “the ends justify the means” and a few brutalized prisoners were a small price to pay for protecting the citizens of the United States.

But, in truth, the use of torture and the practice of cruel, inhuman, and degrading treatment detracted from the military mission and compromised the international stature of our country. It undermined the effectiveness, credibility, and ethical foundations of the medical professionals. Torture and abuse harmed the victims, damaged the perpetrators, and weakened national security. My findings and opinions reflect hundreds of hours of clinical interviews with detainees in Guantanamo and hundreds more reviewing medical records and reports of interrogations. Both the interviews and records expose the techniques of harsh interrogation, including stress positions, extremes of temperature, long-term isolation, waterboarding, sleep deprivation, instilling fear through the use of dogs, threats of death or severe harm, bombardment by loud music, severe humiliation, and physical force.

Research studies, direct clinical observations, and reviews of medical records document the adverse and harmful effects of enhanced interrogation. Sleep manipulation contributes to cognitive impairment and disruption, with psychotic features emerging within 1 week, and it can lead to self-harm, including symptoms resembling paranoid schizophrenia. Sensory deprivation, including hooding and isolation, leads to severe anxiety, depression, and psychotic-like thinking, with serious health consequences. Repetitive exposure to frightening and life-threatening circumstances contributes to debilitating PTSD.

Victims of abusive interrogation suffer with anxiety and depressive disorders, manifest brief psychotic disorders such as delusions and hallucinations, develop obsessive-compulsive disorder, and are at greater risk for suicide. Many are demoralized and hopeless. Statements made by detainees in an impaired mental state when interrogated have not been admissible in court proceedings.

Standing up for human rights has come front and center, as both a matter of national strategy and a measure of human decency. Historically, the human rights stance against torture has been unequivocal, one of the few absolutes in human rights law: It is never permitted, never excused, never to be balanced against national needs or interests-even in cases of national emergency. Torture is forbidden under the laws of war. It is considered a war crime under the Geneva Conventions.

By reflecting on the ethical principles and traditions of our healing professions, a stronger case for national security can be put forward against torture and mistreatment:

 Victims of torture and mistreatment breed political instability and discontent, weakening governments and societies.

 Torture and mistreatment violate the intents and purposes of medical healers, and participation in any way corrupts the ethical foundations of the practitioners and professions.

 Physicians are not interrogators, any more than they are fighter pilots or infantrymen. The military and other government agencies have other professionals to do those tasks, and calling on physicians to fill such roles is irresponsible and ineffective.

Physicians enjoy special trust and confidence across almost all societies. That trust is undermined with participation in harmful, coercive, and abusive conduct that is neither doctor-like nor appropriate.

In 1947, our nation and its allies tried and sentenced the Nazi physicians who violated basic principles of medical ethics. In 2003, the political dynamics and national sentiment induced physicians, including psychiatrists, a well as other health care professionals to commit actions that violated core ethics. Much has improved since the dark days of 9/11, but our nation has been damaged. Where once the symbol of our great democracy was the Statue of Liberty, it has now become the image of that poor hooded man in detention with wires strung from his hands and feet. We have damaged the lives of thousands of people who will suffer the consequences for many decades to come. Our men and women on the front lines are endangered because of the increased risk of retaliatory measures. We are not safer because of these misguided policies and how we have acted as a country. Physicians have a collective duty to oppose torture and abuse-to uphold historically shared beliefs and convictions.

Thomas J. Mental health professionals in the “enhanced” interrogation room. 

Rubenstein LS, Xenakis SN. Doctors without morals. 

http://www.nytimes.com/2010/03/01/opinion/01xenakis.html?scp=1&sq=doctors%20without%20morals%20march%201%202010&st=cse

 The plain fact is that nothing that has been claimed in the name of defending our country can justify cruel, inhuman, and degrading treatment of another man or woman. Torture, in any form-light or heavy-is not a tool of interrogation or useful for gathering good intelligence. 

Stephen N. Xenakis, MD

Articles

The Rise of Cranial Electrotherapy

Condemning Torture and Abuse: A Call to Action