Cranial Electrotherapy Stimulation in Burned Patients

NCT ID: NCT00723008

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-12-31

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.

Conditions

Post Traumatic Stress Disorders; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alpha Stim 100 (Cranial Electrotherapy Stimulation)

Intervention Type: DEVICE

cranial electrical stimulation 100 microamps

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.

Group Type: EXPERIMENTAL

Alpha Stim 100 (Cranial Electrotherapy Stimulation)

Intervention Type: DEVICE

cranial electrical stimulation 100 microamps

Interventions

Alpha Stim 100 (Cranial Electrotherapy Stimulation)

cranial electrical stimulation 100 microamps

Intervention Type: DEVICE

Other Intervention Names

Alpha Stim 100- Electromedical Products International, Inc

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Gaylord, RN, MSN, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

USAISR

Fort Sam Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11682346 (View on PubMed)

Other Identifiers

H-07-024

Identifier Type: -

Identifier Source: org_study_id