Cranial Electrotherapy Stimulation (CES) Therapy

Veterans from conflicts in Afghanistan and Iraq exhibit numerous signature injuries to
include posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), and anxiety.
These three conditions commonly co-occur together, which presents treatment challenges.
First, current treatment guidelines focus on treating each of these conditions individually
and do not sufficiently account for comorbid presentation. As a consequence, Veterans with
comorbid disorders may have poor clinical health outcomes despite receiving treatment.
Second, treating anxiety among Veterans with comorbid PTSD and TBI involves medications that
may have limited efficacy (e.g., PTSD medications) or side effects (e.g., drug interactions
or diminished cognitive function).

Given these treatment challenges, Cranial Electrotherapy Stimulation (CES) may serve as an
effective complimentary, noninvasive/non-pharmacological treatment for this Veteran
population. Briefly, CES is administered through a therapeutic device (such as Alpha-Stim®)
marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain.
Additionally, both the Department of Defense (DoD) and Veterans Health Affairs (VHA)
prescribe CES to treat trauma-related conditions. CES treatment involves transcutaneous
application of pulsed micro-currents of <1000 μA to the patient's head and these currents are
tailored specifically for each patient. The studies that have examined efficacy for CES
therapy in treating anxiety have shown some positive effects, however, the patient
populations were typically small, sometimes limited to case reports, and outcome measures
varied significantly. A meta-analysis performed on CES studies over two decades ago found
evidence for CES treatment over sham groups, but most of the studies reviewed were missing
data and study personnel were not always blinded to the groups. Additionally, CES has showed
a significant improvement in anxiety symptoms after of CES therapy in 12 adult patients
diagnosed with generalized anxiety disorder (GAD; Bystritsky et al., [2008]). The success of
CES in treating anxiety may indicate a suitable signal for exploring its use in PTSD samples
(Novakovic et al. [2011]). Given the relatively few CES studies available in the scholarly
literature, a 2009 Cochrane Systematic Review found insufficient evidence to support using
CES to manage persistent TBI symptoms. While some of these studies are encouraging, the
device has not been clearly demonstrated to be effective in the multi-morbid OEF/OIF/OND
Veteran population. Additionally, little information is known about the mechanism of action
for CES.

Inclusion Criteria:

- Male outpatient, OEF/OIF/OND Veterans diagnosed during the course of clinical care
with mild TBI and PTSD, and screened positive for anxiety

- Good medical health and stable chronic medical conditions.

- No current alcohol or substance abuse.

Exclusion Criteria:

- Patients with moderate or severe TBI or seizure disorders.

- Prior CES use

- Diagnosis of Bipolar Disorder, Schizophrenia, or other psychiatric condition that
would require inpatient hospitalization or medical disease that would impair reliable
participation in the trial.