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

Not Applicable

• Conditions: Combat Related Symptoms; Irritability; Anger

• Registration Number: NCT00866411
• Lead Sponsor: Brooke Army Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Status Verified: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Last Update Submitted: 2009-03-19
• Study First Posted: 2009-03-20
• Last Update Posted: 2009-03-20
• Primary Completion: 2009-05
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Irritability Visual Analog Scale	Baseline, daily x 3 weeks, 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States

Carl R. Darnall Army Medical Center; 🇺🇸 Fort Hood, Texas, United States