Cranial Electrotherapy Stimulation in Burned Patients (CES)

United States Army Institute of Surgical Research

Status and phase: Completed; Phase 2

Conditions: Post Traumatic Stress Disorders; Burns

Treatments: Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00723008

H-07-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

A

Experimental group

Description:

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.

Treatment:

Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)

B

Experimental group

Description:

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.

Treatment:

Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)