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

Sponsor

Brooke Army Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00866411

Collaborator

(none)

100

Enrollment

Locations

32.1

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Combat Related Symptoms Irritability Anger	Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim Procedure: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Anticipated Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Irritability Visual Analog Scale [Baseline, daily x 3 weeks, 4 weeks]

Secondary Outcome Measures

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]
General Sleep Disturbance Scale [Baseline, 3 weeks, 4 weeks]
Sleep Self Care Questionnaire [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]
Medication Use Questionnaire [Baseline, 3 weeks, 4 weeks]
Spielberger State-Trait Anger Expression Inventory-2(STAXI-2) [baseline, 3 weeks, 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.