Skip to main content
OpenTrials
Completed

NCT Number: NCT00723008

Cranial Electrotherapy Stimulation in Burned Patients

To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to some or all of those symptoms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Traumatic Stress Disorders Anxiety Disorders Burns Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

USAISR

Fort Sam Houston, Texas, 78234, United States

About this study

The purpose of this research study is to systematically determine if CES therapy is effective in managing post traumatic stress disorder (PTSD) in the burn patient. Cranial Electrotherapy Stimulation (CES) is the delivery of low-level electrical stimulation across the head, delivered with ear lobe electrode clips or self-adhesive electrode pads. CES in the current form has been used for the past 30 years to successfully treat anxiety, depression, insomnia and pain in a variety of patient populations. This FDA approved medical device is non-invasive and has no reported significant side effects. It will be used on patients undergoing outpatient rehabilitation in our burn center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • burned patients requiring outpatient physical or occupational therapy in the USAISR Burn Rehabilitation Gym or Center for the Intrepid
  • Able to read and speak English
  • Between ages of 18-65 years
  • Screen positive (score greater than 44) on the PCL-M/C instruments

Exclusion criteria

  • pregnant patients
  • patients with implantable pacemakers or electronic stimulators
  • patients scoring below 44 on the PCL-M/C instrument
  • patients who previously used CES therapy

Treatment and study plan

Alpha Stim 100 (Cranial Electrotherapy Stimulation)

Device

cranial electrical stimulation 100 microamps

Other names: Alpha Stim 100- Electromedical Products International, Inc

Primary outcomes

  1. Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score

    Time frame: Baseline, Week 4, Week 8

    Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.

  2. Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score

    Time frame: Baseline, 4 Weeks, 8 Weeks

    This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.

  3. Mean Brief Profile of Mood States (BPOMS) Score

    Time frame: Baseline, Week 4, Week 8

    BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.

  4. Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).

    Time frame: Blinded Period, Unblinded Period

    Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).

  5. Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).

    Time frame: Blinded Period, Unblinded Period

    Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).

  6. Mean General Sleep Disturbance Scale (GSDS) Score

    Time frame: Baseline, Week 4, Week 8

    The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Official study title

Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients

Acronym: CES

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2008
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.