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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Stim 100 (Cranial Electrotherapy Stimulation) | Device | cranial electrical stimulation 100 microamps |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Gaylord, RN, MSN, PhD | United States Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USAISR | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11682346 | Background | 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. |
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Military service members who received outpatient rehabilitation through the US Army Institute of Surgical research (USAISR) were enrolled September 12, 2007-January 9,2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Active/Unblinded | 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. Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps |
| FG001 | B: Sham/Unblinded | 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. Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| 4-Week Double Blinded |
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| 4-Week Unblinded Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Active/Unblinded | 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. Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All active subjects | Posted | Mean | Standard Deviation | Score | Baseline, Week 4, Week 8 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Blinded Phase | Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain, Tingling | Nervous system disorders |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LTC. Elizabeth Mann-Salinas, PhD, RN,CCRN,CCNS | U.S. Army Institute of Surgical Research | 210-916-3527 | Elizabeth.Mann@us.army.mil |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D002056 | Burns |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
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| 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 |
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| BG001 | B: Sham/Unblinded | 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. Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | B: Sham/Unblinded | 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. Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps |
|
|
| Primary | 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. | One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval. | Posted | Mean | Standard Deviation | Score | Baseline, 4 Weeks, 8 Weeks |
|
|
|
| Primary | 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. | One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval. | Posted | Mean | Standard Deviation | Brief POMS Score | Baseline, Week 4, Week 8 |
|
|
|
| Primary | 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). | All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval. | Posted | Mean | Standard Deviation | VAS-P Score | Blinded Period, Unblinded Period |
|
|
|
| Primary | 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). | All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval | Posted | Mean | Standard Deviation | VAS-A Score | Blinded Period, Unblinded Period |
|
|
|
| Primary | 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. | All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval. | Posted | Mean | Standard Deviation | Score | Baseline, Week 4, Week 8 |
|
|
|
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | Group A: Unblinded Phase | Subjects using 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). | 0 | 5 | 1 | 5 |
| EG002 | Group B: Blinded Phase | Subjects receiving sham CES treatment for 1 hour daily for 4 weeks. | 0 | 9 | 5 | 9 |
| EG003 | Group B: Unblinded Phase | Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks. | 0 | 4 | 3 | 4 |
| Headache | Nervous system disorders |
|
| Increased Irritability | Psychiatric disorders |
|
| Increased Injury Site Pain | Nervous system disorders |
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| Lightheadedness | Nervous system disorders |
|
| Nausea | Gastrointestinal disorders |
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| Night Terrors | Psychiatric disorders |
|
| Stiffness/ soreness | Musculoskeletal and connective tissue disorders |
|
| Insomnia | Psychiatric disorders |
|
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| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Week 8 |
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| Week 8 |
|
| Unblinded: Open Label Sensate Period |
|
| Unblinded, Open Label Sensate Period |
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| Week 8 |
|