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

NCT ID: NCT00866411

Last Updated: 2009-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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Combat Related Symptoms Irritability Anger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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cranial electrotherapy stimulation (CES) with Alpha-Stim

three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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cranial electrotherapy stimulation CES Alpha-Stim bioelectric medicine

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Brooke Army Medical Center

Principal Investigators

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Mona O Bingham, PhD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

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Carl R. Darnall Army Medical Center

Fort Hood, Texas, United States

Site Status RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Sharon Reese, AN, DrPH

Role: primary

254-288-8577

Mona O Bingham, PhD

Role: primary

210-916-7159

Stacey Young-McCaughan, PhD

Role: backup

(210) 567-1942

Other Identifiers

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C.2007.147

Identifier Type: -

Identifier Source: org_study_id

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