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

Study Overview
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Brief Summary
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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.

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

Conditions
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Combat Related Symptoms, Irritability, Anger

Intervention / Treatment
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* Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim
* Procedure: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim|three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)|
|Procedure: placebo|three weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritability Visual Analog Scale |  | Baseline, daily x 3 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cranial electrotherapy stimulation, anxiety, depression, pain, sleep disturbance, combat exposure, post traumatic stress, health status, medication use, soldiers