Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms
NCT ID: NCT00866411
Last Updated: 2009-03-20
Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2007-05-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Soldiers who score 4 or greater on the visual analog scale for irritability
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Brooke Army Medical Center
FED
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
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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C.2007.147
Identifier Type: -
Identifier Source: org_study_id
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