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

March 19, 2009 updated by: Brooke Army Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Recruiting
        • Carl R. Darnall Army Medical Center
        • Contact:
      • Fort Sam Houston, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Irritability Visual Analog Scale
Time Frame: Baseline, daily x 3 weeks, 4 weeks
Baseline, daily x 3 weeks, 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Mona O Bingham, PhD, Brooke Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2009

Last Update Submitted That Met QC Criteria

March 19, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C.2007.147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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