Phase 2
N=20
Cranial Electrotherapy Stimulation in Burned Patients
Post Traumatic Stress Disorders · Burns
Bottom Line
View on ClinicalTrials.gov: NCT00723008 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score — 53.8; 56.7; 48.8; 50.4 Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alpha Stim 100 (Cranial Electrotherapy Stimulation) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United States Army Institute of Surgical Research
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score |
53.8; 56.7; 48.8; 50.4; 55.5; 44.7 | — |
| PRIMARY Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score |
28.8; 30.6; 27.5; 24.5; 36.3; 21.7 | — |
| PRIMARY Mean Brief Profile of Mood States (BPOMS) Score |
50.2; 55.9; 42.3; 50.3; 51.0; 41.0 | — |
| PRIMARY Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). |
3.7; 3.3; 3.9; 4.2; 2.9; 2.3 | — |
| PRIMARY Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). |
3.6; 3.2; 3.3; 3.3; 2.6; 2.1 | — |
| PRIMARY Mean General Sleep Disturbance Scale (GSDS) Score |
76.3; 90.8; 80.6; 83.3; 67.8; 56.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00723008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.