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

• State Anxiety Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Epworth Sleepiness Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• General Sleep Disturbance Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Sleep Self Care Questionnaire [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Combat Exposure Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
• Trauma Imagery Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• State - Anxiety Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Profile of Mood States [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Visual Analog [ Time Frame: Daily x 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Center for Epidemiological Center for Epidemiological Studies - Depression Scale [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Depression Visual Analog [ Time Frame: Daily x 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• PTSD CheckList - Military Version [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Veteran's Outcomes Survey Short Form - 36 [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Medication Use Questionnaire [ Time Frame: Baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
• Spielberger State-Trait Anger Expression Inventory-2(STAXI-2) [ Time Frame: baseline, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]

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.

• Combat Related Symptoms
• Irritability
• Anger

• Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim
  three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)
  Other Names:

  • cranial electrotherapy stimulation
  • CES
  • Alpha-Stim
  • bioelectric medicine
• 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

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.