Cranial Electrotherapy Stimulation (CES) Therapy

NCT ID: NCT02453347

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

TBI; Anxiety; PTSD; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CES Therapy

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.

Group Type: EXPERIMENTAL

CES Therapy

Intervention Type: DEVICE

Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain.

Interventions

CES Therapy

Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain.

Intervention Type: DEVICE

Other Intervention Names

Cranial Electrotherapy Stimulation (CES) Therapy; Alpha Stim

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos A Jaramillo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

San Antonio Polytrauma Center South Texas Veterans Health Care System

Locations

Audie L. Murphy VA Hospital

San Antonio, Texas, United States

Countries

United States

Other Identifiers

15-352H (UTHSCSA IRB)

Identifier Type: -

Identifier Source: org_study_id