Burns, Post Traumatic Stress Disorders
Conditions
Keywords
anxiety, insomnia, pain, Alpha Stim, Cranial electrotherapy stimulation
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.
Interventions
DEVICEAlpha Stim 100 (Cranial Electrotherapy Stimulation)
cranial electrical stimulation 100 microamps
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Baseline, Week 4, Week 8 | 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 | Baseline, 4 Weeks, 8 Weeks | 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 | Baseline, Week 4, Week 8 | 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). | Blinded Period, Unblinded Period | 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). | Blinded Period, Unblinded Period | 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 | Baseline, Week 4, Week 8 | 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. |
Countries
United States
Participant flow
Recruitment details
Military service members who received outpatient rehabilitation through the US Army Institute of Surgical research (USAISR) were enrolled September 12, 2007-January 9,2009.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 4-Week Double Blinded | Lack of Efficacy | 0 | 1 |
| 4-Week Double Blinded | Lost to Follow-up | 4 | 3 |
| 4-Week Double Blinded | Withdrawal by Subject | 1 | 1 |
| 4-Week Unblinded Treatment | Adverse Event | 1 | 0 |
| 4-Week Unblinded Treatment | Lost to Follow-up | 0 | 1 |
| Enrollment | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | A: Active/Unblinded | B: Sham/Unblinded | Total |
|---|---|---|---|
| Age Continuous | 26.3 years STANDARD_DEVIATION 4.9 | 27.3 years STANDARD_DEVIATION 4.9 | 26.8 years STANDARD_DEVIATION 4.8 |
| Race/Ethnicity, Customized African American | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian | 5 participants | 8 participants | 13 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Other, not specified | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 11 | 1 / 5 | 5 / 9 | 3 / 4 |
| serious Total, serious adverse events | 0 / 11 | 0 / 5 | 0 / 9 | 0 / 4 |
Outcome results
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.
Time frame: Baseline, Week 4, Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Baseline | 50.2 Brief POMS Score | Standard Deviation 21.7 |
| A: Active/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Week 4 | 42.3 Brief POMS Score | Standard Deviation 21.9 |
| A: Active/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Week 8 | 51.0 Brief POMS Score | Standard Deviation 11.5 |
| B: Sham/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Baseline | 55.9 Brief POMS Score | Standard Deviation 15.4 |
| B: Sham/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Week 4 | 50.3 Brief POMS Score | Standard Deviation 10.3 |
| B: Sham/Unblinded | Mean Brief Profile of Mood States (BPOMS) Score | Week 8 | 41.0 Brief POMS Score | Standard Deviation 9.9 |
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.
Time frame: Baseline, 4 Weeks, 8 Weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Baseline | 28.8 Score | Standard Deviation 8.9 |
| A: Active/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Week 4 | 27.5 Score | Standard Deviation 8.2 |
| A: Active/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Week 8 | 36.3 Score | Standard Deviation 4.5 |
| B: Sham/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Baseline | 30.6 Score | Standard Deviation 9.9 |
| B: Sham/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Week 4 | 24.5 Score | Standard Deviation 13 |
| B: Sham/Unblinded | Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score | Week 8 | 21.7 Score | Standard Deviation 9.8 |
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.
Time frame: Baseline, Week 4, Week 8
Population: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Week 8 | 67.8 Score | Standard Deviation 30 |
| A: Active/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Baseline | 76.3 Score | Standard Deviation 22.7 |
| A: Active/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Week 4 | 80.6 Score | Standard Deviation 16.4 |
| B: Sham/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Week 8 | 56.3 Score | Standard Deviation 14.6 |
| B: Sham/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Baseline | 90.8 Score | Standard Deviation 13 |
| B: Sham/Unblinded | Mean General Sleep Disturbance Scale (GSDS) Score | Week 4 | 83.3 Score | Standard Deviation 14.8 |
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.
Time frame: Baseline, Week 4, Week 8
Population: All active subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Baseline | 53.8 Score | Standard Deviation 16.4 |
| A: Active/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Week 4 | 48.8 Score | Standard Deviation 15.3 |
| A: Active/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Week 8 | 55.5 Score | Standard Deviation 14.8 |
| B: Sham/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Baseline | 56.7 Score | Standard Deviation 9.6 |
| B: Sham/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Week 4 | 50.4 Score | Standard Deviation 17.1 |
| B: Sham/Unblinded | Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score | Week 8 | 44.7 Score | Standard Deviation 2.1 |
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).
Time frame: Blinded Period, Unblinded Period
Population: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period | 3.6 VAS-A Score | Standard Deviation 2.1 |
| A: Active/Unblinded | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded, Open Label Sensate Period | 2.6 VAS-A Score | Standard Deviation 1.9 |
| B: Sham/Unblinded | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded, Open Label Sensate Period | 2.1 VAS-A Score | Standard Deviation 1.7 |
| B: Sham/Unblinded | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period | 3.2 VAS-A Score | Standard Deviation 2.2 |
| Group B: BEFORE Sham or CES Treatment | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded, Open Label Sensate Period | 2.8 VAS-A Score | Standard Deviation 1.1 |
| Group B: BEFORE Sham or CES Treatment | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period | 3.3 VAS-A Score | Standard Deviation 1.7 |
| Group B: AFTER Sham or CES Treatment | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded, Open Label Sensate Period | 2.3 VAS-A Score | Standard Deviation 1.5 |
| Group B: AFTER Sham or CES Treatment | Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period | 3.3 VAS-A Score | Standard Deviation 1.7 |
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).
Time frame: Blinded Period, Unblinded Period
Population: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A: Active/Unblinded | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period: CES or Sham | 3.7 VAS-P Score | Standard Deviation 1.7 |
| A: Active/Unblinded | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded: Open Label Sensate Period | 2.9 VAS-P Score | Standard Deviation 2.1 |
| B: Sham/Unblinded | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded: Open Label Sensate Period | 2.3 VAS-P Score | Standard Deviation 1.7 |
| B: Sham/Unblinded | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period: CES or Sham | 3.3 VAS-P Score | Standard Deviation 1.9 |
| Group B: BEFORE Sham or CES Treatment | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period: CES or Sham | 3.9 VAS-P Score | Standard Deviation 1.5 |
| Group B: BEFORE Sham or CES Treatment | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded: Open Label Sensate Period | 3.3 VAS-P Score | Standard Deviation 1.4 |
| Group B: AFTER Sham or CES Treatment | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Blinded Period: CES or Sham | 4.2 VAS-P Score | Standard Deviation 1.7 |
| Group B: AFTER Sham or CES Treatment | Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES). | Unblinded: Open Label Sensate Period | 2.8 VAS-P Score | Standard Deviation 1.9 |