Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms

Brooke Army Medical Center2 sites in 1 country100 target enrollmentMay 2007

ConditionsCombat Related Symptoms Irritability Anger

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Combat Related Symptoms
Sponsor: Brooke Army Medical Center
Enrollment: 100
Locations: 2
Primary Endpoint: Irritability Visual Analog Scale
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

January 2010

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brooke Army Medical Center

Eligibility Criteria

Inclusion Criteria

•Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
•Soldiers who score 4 or greater on the visual analog scale for irritability

Exclusion Criteria

•Seizure disorders.
•Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
•Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
•Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.

Outcomes

Primary Outcomes

Irritability Visual Analog Scale

Time Frame: Baseline, daily x 3 weeks, 4 weeks

Secondary Outcomes

Sleep Self Care Questionnaire(Baseline, 3 weeks, 4 weeks)
State Anxiety Scale(Baseline, 3 weeks, 4 weeks)
Pittsburgh Sleep Quality Index(Baseline, 3 weeks, 4 weeks)
Epworth Sleepiness Scale(Baseline, 3 weeks, 4 weeks)
Medication Use Questionnaire(Baseline, 3 weeks, 4 weeks)
Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)(baseline, 3 weeks, 4 weeks)
General Sleep Disturbance Scale(Baseline, 3 weeks, 4 weeks)
Combat Exposure Scale(Baseline)
Trauma Imagery Scale(Baseline, 3 weeks, 4 weeks)
State - Anxiety Scale(Baseline, 3 weeks, 4 weeks)
Profile of Mood States(Baseline, 3 weeks, 4 weeks)
Visual Analog(Daily x 3 weeks, 4 weeks)
Center for Epidemiological Center for Epidemiological Studies - Depression Scale(Baseline, 3 weeks, 4 weeks)
Depression Visual Analog(Daily x 3 weeks, 4 weeks)
PTSD CheckList - Military Version(Baseline, 3 weeks, 4 weeks)
Veteran's Outcomes Survey Short Form - 36(Baseline, 3 weeks, 4 weeks)