For the first time, a trial in a small group of patients shows that a new type of treatment for epilepsy and depression that uses an external, wearable electrical brain stimulator could significantly reduce severity of chronic post-traumatic stress disorder.
The treatment - called external trigeminal nerve stimulation (eTNS) - uses a 9-volt battery to power a patch that is stuck on the forehead.
While the patient is asleep, a weak electric current passes through the patch and stimulates cranial nerves that run through the forehead, causing them to send signals to parts of the brain that control mood, behavior and thinking.
The parts of the brain affected include the amygdala, media prefrontal cortex and the autonomic nervous system - all of which are known to show abnormal activity in people with post-traumatic stress disorder (PTSD).
Results of the new trial - led by the University of California-Los Angeles (UCLA) - have been presented at three academic conferences and are published in the journal Neuromodulation: Technology at the Neural Interface.
The paper describes how the eTNS treatment brought considerable relief to 12 patients - survivors of car accidents, rape, domestic abuse and other traumatic events - who were suffering with chronic PTSD and severe depression.
The traumas - which, on average, had occurred about 30 years before the trial - had left the patients unable to sleep, prone to nightmares, irritable and hypervigilant, as well as anxious and depressed.
'For the first time in years I slept through the night'
Senior author Andrew Leuchter, UCLA professor of psychiatry, says eTNS could be a breakthrough for PTSD patients who are not helped by current treatments. He says that while most do get some benefit, the majority still have symptoms that persist for years.
- Even though over 50% of people experience at least one trauma in their lives, a much smaller proportion develop PTSD
- About 8 million Americans are living with PTSD
- Women are more likely to develop PTSD than men.
He describes the treatment as "extraordinarily powerful" and remarks:
"We're talking about patients for whom illness had almost become a way of life. Yet they were coming in and saying: 'For the first time in years I slept through the night,' or 'My nightmares are gone.'"
Prof. Leuchter, who is also a staff psychiatrist at the VA Greater Los Angeles Healthcare System - part of the US Department of Veterans Affairs - and colleagues conducted the trial primarily with civilian volunteers.
They plan to recruit military veterans for the next phase of the research, which will involve a larger trial.
Military veterans are at greater risk for PTSD than civilians. An estimated 17% of active military personnel experience symptoms, and around 30% of veterans returning from service in Iraq and Afghanistan have had symptoms, note the authors.
PTSD can interfere with ability to lead a normal life and raises risk of suicide. Patients experience difficulties working with others, having families and maintaining relationships. To avoid situations that could trigger flashbacks, many lead lives of isolation, with little social life or travel.
PTSD symptoms reduced by 30%, depression by 50%
For the trial, the 12 PTSD patients of average age 53 years underwent 8 weeks of eTNS outpatient treatment. The patients wore the electrical forehead patch for 8 hours every night while they slept.
During the study, the patients continued with any treatments they were already receiving, such as psychotherapy, medication or both.
The patients completed questionnaires before and after the treatment - from these, the researchers could assess the severity of their symptoms and the extent to which they interfered with their daily lives, family relationships, parenting and socializing.
When they analyzed the results, the researchers found that, on average, patients' PTSD symptoms fell by over 30% and the severity of their depression by over 50%.
They also note that in a quarter of patients, the PTSD symptoms went into remission. The patients also reported a general increase in ability to participate in everyday activities.
With the collaboration of the VA Greater Los Angeles Healthcare System, the next trial will involve 74 veterans in two groups - one will be fitted with a "real" eTNS and the other with a "dummy" or placebo version. At the end of the trial, the participants who had the dummy eTNS will have the option of undergoing treatment with real eTNS.
Lead author Ian Cook co-invented TNS at UCLA. He is currently on leave from various UCLA posts - including professor of psychiatry and biobehavioral sciences at the David Geffen School of Medicine - to serve as chief medical officer at Neurosigma in Los Angeles.
Prof. Cook likens having PTSD to having invisible wounds:
"The scars are inside but they can be just as debilitating as visible scars."
Neurosigma are licensing the technology and funding the research. The company is already marketing the device overseas and plans to make it available to patients in the US.
In September 2015, Medical News Today learned of a JAMA Psychiatry study that found low heart rate variability may influence PTSD risk in military personnel returning from combat deployment.