Cranial Electrotherapy Stimulation in Burned Patients

NCT00723008 | Completed Phase 2 Results

• 1 other identifier: H-07-024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorders; Burns

Keywords

anxiety; insomnia; pain; Alpha Stim; Cranial electrotherapy stimulation

Outcome Measures

Primary Outcomes (6)

• Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score

  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.

  Baseline, Week 4, Week 8

• Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score

  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.

  Baseline, 4 Weeks, 8 Weeks

• Mean Brief Profile of Mood States (BPOMS) Score

  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.

  Baseline, Week 4, Week 8

• Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).

  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).

  Blinded Period, Unblinded Period

• Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).

  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).

  Blinded Period, Unblinded Period

• Mean General Sleep Disturbance Scale (GSDS) Score

  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.

  Baseline, Week 4, Week 8

Study Arms (2)

A

EXPERIMENTAL

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)

B

EXPERIMENTAL

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)

Interventions

Alpha Stim 100 (Cranial Electrotherapy Stimulation) DEVICE

cranial electrical stimulation 100 microamps

Also known as: Alpha Stim 100- Electromedical Products International, Inc

A; B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead

Study Sites (1)

USAISR

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• 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.

  PMID: 11682346 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Burns; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study had a high study turn-over rate, which led to small data group analysis. All subjects enrolled were active military service men. This made civilian and female comparison impossible. The PI also changed during study course.

Results Point of Contact

• Title: LTC. Elizabeth Mann-Salinas, PhD, RN,CCRN,CCNS
• Organization: U.S. Army Institute of Surgical Research

Elizabeth.Mann@us.army.mil

210-916-3527

Study Officials

• Kathryn Gaylord, RN, MSN, PhD

  United States Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: July 28, 2008
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 22, 2013
• Results First Posted: March 22, 2013

Record last verified: 2013-02

Locations

US (1)