Clinical trial NCT00723008: Cranial Electrotherapy Stimulation in Burned Patients
Official title: Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorders
Burns
Keywords: anxiety
insomnia
pain
Alpha Stim
Cranial electrotherapy stimulation
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2008-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
timeFrame: Baseline, Week 4, Week 8
measure: Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score
timeFrame: Baseline, 4 Weeks, 8 Weeks
measure: Mean Brief Profile of Mood States (BPOMS) Score
timeFrame: Baseline, Week 4, Week 8
measure: Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).
timeFrame: Blinded Period, Unblinded Period
measure: Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).
timeFrame: Blinded Period, Unblinded Period
measure: Mean General Sleep Disturbance Scale (GSDS) Score
timeFrame: Baseline, Week 4, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: USAISR
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Kathryn Gaylord, RN, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroeder MJ, Barr RE. Quantitative analysis of the electroencephalogram during cranial electrotherapy stimulation. Clin Neurophysiol. 2001 Nov;112(11):2075-83. doi: 10.1016/s1388-2457(01)00657-5.