Cranial Electrotherapy Stimulation in Burned Patients (CES)

• ClinicalTrials.gov Identifier: NCT00723008
• Recruitment Status: Completed
• First Posted: July 28, 2008
• Results First Posted: March 22, 2013
• Last Update Posted: March 22, 2013
• Sponsor: United States Army Institute of Surgical Research
• Information provided by (Responsible Party): United States Army Institute of Surgical Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Post Traumatic Stress Disorders; Burns	Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients
• Study Start Date: May 2007
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.	Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation); cranial electrical stimulation 100 microamps; Other Name: Alpha Stim 100- Electromedical Products International, Inc
Experimental: B; Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.	Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation); cranial electrical stimulation 100 microamps; Other Name: Alpha Stim 100- Electromedical Products International, Inc

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

USAISR

Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

• Principal Investigator: Kathryn Gaylord, RN, MSN, PhD; United States Army Institute of Surgical Research

More Information

Publications:

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

• Responsible Party: United States Army Institute of Surgical Research
• ClinicalTrials.gov Identifier: NCT00723008
• Other Study ID Numbers: H-07-024
• First Posted: July 28, 2008
• Results First Posted: March 22, 2013
• Last Update Posted: March 22, 2013
• Last Verified: February 2013

Keywords provided by United States Army Institute of Surgical Research:

anxiety; insomnia; pain; Alpha Stim; Cranial electrotherapy stimulation

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders