Clinical trial NCT00866411: Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms
Official title: Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Combat Related Symptoms
Irritability
Anger
Keywords: cranial electrotherapy stimulation
anxiety
depression
pain
sleep disturbance
combat exposure
post traumatic stress
health status
medication use
soldiers
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2009-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 irritability.


Eligibility criteria: 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.

Primary outcomes:
measure: Irritability Visual Analog Scale
timeFrame: Baseline, daily x 3 weeks, 4 weeks
Secondary outcomes:
measure: State Anxiety Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Epworth Sleepiness Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: General Sleep Disturbance Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Sleep Self Care Questionnaire
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Combat Exposure Scale
timeFrame: Baseline
measure: Trauma Imagery Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: State - Anxiety Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Profile of Mood States
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Visual Analog
timeFrame: Daily x 3 weeks, 4 weeks
measure: Center for Epidemiological Center for Epidemiological Studies - Depression Scale
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Depression Visual Analog
timeFrame: Daily x 3 weeks, 4 weeks
measure: PTSD CheckList - Military Version
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Veteran's Outcomes Survey Short Form - 36
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Medication Use Questionnaire
timeFrame: Baseline, 3 weeks, 4 weeks
measure: Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)
timeFrame: baseline, 3 weeks, 4 weeks
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Mona O Bingham, PhD
role: PRINCIPAL_INVESTIGATOR
References: