Clinical trial NCT02453347: Cranial Electrotherapy Stimulation (CES) Therapy
Official title: Cranial Electrotherapy Stimulation (CES) Therapy for PTSD and Anxiety in OEF/OIF Veterans With Mild TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI
Anxiety
PTSD
Depression
Keywords: Stable chronic medical conditions
No current alcohol or substance abuse
Alpha Stim
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms
timeFrame: Four Weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Four Weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 4 weeks
measure: TFI (Tinnitus Functional Index)
timeFrame: 4 weeks
measure: MPAI (Mayo Portland Adaptability Inventory)
timeFrame: 4 weeks
measure: WAIS (Wechsler Adult Intelligence Scale) Symbol Search
timeFrame: 4 weeks
measure: WAIS Coding - Wechsler Adult Intelligence Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Dizziness- NSI (Neurobehavioral Symptom Inventory)
timeFrame: Four Weeks
measure: Headache - HIT6 (Headache Impact Test)
timeFrame: Four Weeks
measure: Sleep - Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Four Weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie L. Murphy VA Hospital
state: Texas
Study officials:
affiliation: San Antonio Polytrauma Center South Texas Veterans Health Care System
name: Carlos A Jaramillo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: