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

NCT00866411 | Unknown DMC

• 1 other identifier: C.2007.147
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Irritability Visual Analog Scale

  Baseline, daily x 3 weeks, 4 weeks

Secondary Outcomes (16)

• State Anxiety Scale

  Baseline, 3 weeks, 4 weeks

• Pittsburgh Sleep Quality Index

  Baseline, 3 weeks, 4 weeks

• Epworth Sleepiness Scale

  Baseline, 3 weeks, 4 weeks

• General Sleep Disturbance Scale

  Baseline, 3 weeks, 4 weeks

• Sleep Self Care Questionnaire

  Baseline, 3 weeks, 4 weeks

Interventions

cranial electrotherapy stimulation (CES) with Alpha-Stim PROCEDURE

three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)

Also known as: cranial electrotherapy stimulation, CES, Alpha-Stim, bioelectric medicine

placebo PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (2)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pain; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mona O Bingham, PhD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

US (2)