Recruiting

Cranial Electrotherapy Stimulation

Sponsor:

Brooke Army Medical Center

Code:

NCT00866411

Conditions

Combat Related Symptoms

Irritability

Anger

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cranial electrotherapy stimulation (CES) with Alpha-Stim

placebo

Study Details

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

Study ID

NCT00866411

Start date

May, 2007

Status verified date

Mar, 2009

Completion date

Jan, 2010

Anticipated

Primary completion date

May, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Irritability Visual Analog Scale [ Time Frame: Baseline, daily x 3 weeks, 4 weeks ]

Central Contacts and Locations

Locations

Carl R. Darnall Army Medical Center

Recruiting

Fort Hood, Texas, United States, 76544

Contacts

Sharon Reese, AN, DrPH

254-288-8577sharon.reese@amedd.army.mil

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Mona O Bingham, PhD

210-916-7159mona.bingham@amedd.army.mil

Stacey Young-McCaughan, PhD

(210) 567-1942stacey.young-mccaughan@us.army.mil

Principal Investigator:

Mona O Bingham, PhD

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Mar 20, 2009

Last verified

Mar, 2009

Keywords

  • cranial electrotherapy stimulation
  • anxiety
  • depression
  • pain
  • sleep disturbance
  • combat exposure
  • post traumatic stress
  • health status
  • medication use
  • soldiers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2009-03-20.