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

Anger Clinical Trial

— CES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00866411
• Other study ID #: C.2007.147
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2009
• Last updated: March 19, 2009
• Start date: May 2007
• Est. completion date: January 2010

Study information

• Verified date: March 2009
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anger
• Combat Related Symptoms
• Irritability

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritability Visual Analog Scale		Baseline, daily x 3 weeks, 4 weeks	No
Secondary	State Anxiety Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	Pittsburgh Sleep Quality Index		Baseline, 3 weeks, 4 weeks	No
Secondary	Epworth Sleepiness Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	General Sleep Disturbance Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	Sleep Self Care Questionnaire		Baseline, 3 weeks, 4 weeks	No
Secondary	Combat Exposure Scale		Baseline	No
Secondary	Trauma Imagery Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	State - Anxiety Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	Profile of Mood States		Baseline, 3 weeks, 4 weeks	No
Secondary	Visual Analog		Daily x 3 weeks, 4 weeks	No
Secondary	Center for Epidemiological Center for Epidemiological Studies - Depression Scale		Baseline, 3 weeks, 4 weeks	No
Secondary	Depression Visual Analog		Daily x 3 weeks, 4 weeks	No
Secondary	PTSD CheckList - Military Version		Baseline, 3 weeks, 4 weeks	No
Secondary	Veteran's Outcomes Survey Short Form - 36		Baseline, 3 weeks, 4 weeks	No
Secondary	Medication Use Questionnaire		Baseline, 3 weeks, 4 weeks	No
Secondary	Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)		baseline, 3 weeks, 4 weeks	No