Status:
UNKNOWN
Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Combat Related Symptoms
Irritability
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 irritabi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00866411
Start Date
May 1 2007
End Date
January 1 2010
Last Update
March 20 2009
Active Locations (2)
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1
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
2
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234