Cranial Electrotherapy Stimulation in Burned Patients (CES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00723008
First received: December 25, 2007
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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 Phase
Post Traumatic Stress Disorders
Burns
Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score [ Time Frame: Baseline, 4 Weeks, 8 Weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Brief Profile of Mood States (BPOMS) Score [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). [ Time Frame: Blinded Period, Unblinded Period ] [ Designated as safety issue: No ]
    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).

  • Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). [ Time Frame: Blinded Period, Unblinded Period ] [ Designated as safety issue: No ]
    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).

  • Mean General Sleep Disturbance Scale (GSDS) Score [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)
cranial electrical stimulation 100 microamps
Other Name: Alpha Stim 100- Electromedical Products International, Inc
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.
Device: Alpha Stim 100 (Cranial Electrotherapy Stimulation)
cranial electrical stimulation 100 microamps
Other Name: Alpha Stim 100- Electromedical Products International, Inc

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723008

Locations
United States, Texas
USAISR
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Kathryn Gaylord, RN, MSN, PhD United States Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00723008     History of Changes
Other Study ID Numbers: H-07-024
Study First Received: December 25, 2007
Results First Received: October 9, 2012
Last Updated: February 19, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
anxiety
insomnia
pain
Alpha Stim
Cranial electrotherapy stimulation

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014