Cranial Electrotherapy Stimulation in Burned Patients

Burns Clinical Trial

— CES  

Official title:

Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723008
• Other study ID #: H-07-024
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: February 19, 2013
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Burns
• Post Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Alpha Stim 100 (Cranial Electrotherapy Stimulation)
cranial electrical stimulation 100 microamps

Locations

Country	Name	City	State
United States	USAISR	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schroeder MJ, Barr RE. Quantitative analysis of the electroencephalogram during cranial electrotherapy stimulation. Clin Neurophysiol. 2001 Nov;112(11):2075-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score	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.	Baseline, Week 4, Week 8	No
Primary	Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score	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.	Baseline, 4 Weeks, 8 Weeks	No
Primary	Mean Brief Profile of Mood States (BPOMS) Score	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.	Baseline, Week 4, Week 8	No
Primary	Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).	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).	Blinded Period, Unblinded Period	No
Primary	Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).	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).	Blinded Period, Unblinded Period	No
Primary	Mean General Sleep Disturbance Scale (GSDS) Score	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.	Baseline, Week 4, Week 8	No