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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Brooke Army Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Brooke Army Medical Center Identifier:
First received: March 19, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Intervention
Combat Related Symptoms
Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim
Procedure: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Irritability Visual Analog Scale [ Time Frame: Baseline, daily x 3 weeks, 4 weeks ]

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

Estimated Enrollment: 100
Study Start Date: May 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00866411

United States, Texas
Carl R. Darnall Army Medical Center Recruiting
Fort Hood, Texas, United States, 76544
Contact: Sharon Reese, AN, DrPH    254-288-8577   
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Mona O Bingham, PhD    210-916-7159   
Contact: Stacey Young-McCaughan, PhD    (210) 567-1942   
Principal Investigator: Mona O Bingham, PhD         
Sponsors and Collaborators
Brooke Army Medical Center
Principal Investigator: Mona O Bingham, PhD Brooke Army Medical Center
  More Information

Responsible Party: LTC Mona O. Bingham, PhD, RN; Chief Nursing Reseach, Brooke Army Medical Center Identifier: NCT00866411     History of Changes
Other Study ID Numbers: C.2007.147
Study First Received: March 19, 2009
Last Updated: March 19, 2009

Keywords provided by Brooke Army Medical Center:
cranial electrotherapy stimulation
sleep disturbance
combat exposure
post traumatic stress
health status
medication use
soldiers processed this record on May 25, 2017