Cranial Electrotherapy Stimulation (CES) Therapy

The University of Texas System (UT)

Status: Completed

Conditions: PTSD; Depression; TBI; Anxiety

Treatments: Device: CES Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02453347

15-352H (UTHSCSA IRB)

Details and patient eligibility

About

The primary aim of this proposed study is to gather preliminary data for CES use in treating PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.

Full description

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.

Enrollment: 6 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

CES Therapy

Experimental group

Description:

All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.

Treatment:

Device: CES Therapy