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

Combat Related Symptoms research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Combat Related Symptoms

Irritability

Anger

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:cranial electrotherapy stimulation (CES) with Alpha-Stimthree weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)

Procedure:placebothree 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: May 2007

Completed Date: January 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Irritability Visual Analog Scale

Secondary Outcome: State Anxiety Scale

Study sponsors, principal investigator, and references

Principal Investigator: Mona O Bingham, PhD

Lead Sponsor: Brooke Army Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00866411

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