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

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Brooke Army Medical Center

Status

Unknown

Conditions

Anger
Irritability
Combat Related Symptoms

Treatments

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

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00866411
C.2007.147

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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