- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00723008
Cranial Electrotherapy Stimulation in Burned Patients (CES)
February 19, 2013 updated by: United States Army Institute of Surgical Research
Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- USAISR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
cranial electrical stimulation 100 microamps
Other Names:
|
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.
|
cranial electrical stimulation 100 microamps
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 4, Week 8
|
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.
|
Baseline, 4 Weeks, 8 Weeks
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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.
|
Baseline, Week 4, Week 8
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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).
|
Blinded Period, Unblinded Period
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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).
|
Blinded Period, Unblinded Period
|
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.
|
Baseline, Week 4, Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kathryn Gaylord, RN, MSN, PhD, United States Army Institute of Surgical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 25, 2007
First Submitted That Met QC Criteria
July 24, 2008
First Posted (Estimate)
July 28, 2008
Study Record Updates
Last Update Posted (Estimate)
March 22, 2013
Last Update Submitted That Met QC Criteria
February 19, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-07-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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