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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Brooke Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00866411
First received: March 19, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Irritability
Anger
Procedure: cranial electrotherapy stimulation (CES) with Alpha-Stim
Procedure: placebo

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00866411

Locations
United States, Texas
Carl R. Darnall Army Medical Center Recruiting
Fort Hood, Texas, United States, 76544
Contact: Sharon Reese, AN, DrPH    254-288-8577    sharon.reese@amedd.army.mil   
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Mona O Bingham, PhD    210-916-7159    mona.bingham@amedd.army.mil   
Contact: Stacey Young-McCaughan, PhD    (210) 567-1942    stacey.young-mccaughan@us.army.mil   
Principal Investigator: Mona O Bingham, PhD         
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: Mona O Bingham, PhD Brooke Army Medical Center
  More Information

No publications provided

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

Keywords provided by Brooke Army Medical Center:
cranial electrotherapy stimulation
anxiety
depression
pain
sleep disturbance
combat exposure
post traumatic stress
health status
medication use
soldiers

ClinicalTrials.gov processed this record on July 24, 2014