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Sponsored by: |
United States Army Institute of Surgical Research |
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Information provided by: | United States Army Institute of Surgical Research |
ClinicalTrials.gov Identifier: | NCT00723008 |
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 | Intervention |
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Post Traumatic Stress Disorders Burns |
Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Alpha Stim 100 will be used for a time period of 2 weeks on and 2 weeks off.
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Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)
device
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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.rn patient undergoing outpatient rehabilitation in our burn center.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn A. Gaylord, RN, MSN, PhD | 210-916-0859 | kathryn.gaylord@amedd.army.mil |
Contact: Annette R. McClinton, RN, MA | 210-916-2834 | annette.mcclinton@amedd.army.mil |
United States, Texas | |
USAISR | Recruiting |
Fort Sam Houston, Texas, United States, 78234 |
Principal Investigator: | Kathryn Gaylord, RN, MSN, PhD | United States Army Institute of Surgical Research |
Responsible Party: | USAISR ( Kathryn Gaylord, COL, AN ) |
Study ID Numbers: | H-07-024 |
Study First Received: | December 25, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00723008 |
Health Authority: | United States: Federal Government |
anxiety insomnia pain Alpha Stim Cranial electrotherapy stimulation |
Burns Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic |
Stress Pain Stress Disorders, Traumatic |