Trial Outcomes & Findings for Cranial Electrotherapy Stimulation in Burned Patients (NCT NCT00723008)
NCT ID: NCT00723008
Last Updated: 2013-03-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Week 4, Week 8
Results posted on
2013-03-22
Participant Flow
Military service members who received outpatient rehabilitation through the US Army Institute of Surgical research (USAISR) were enrolled September 12, 2007-January 9,2009.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Enrollment
STARTED
|
11
|
9
|
|
Enrollment
COMPLETED
|
10
|
9
|
|
Enrollment
NOT COMPLETED
|
1
|
0
|
|
4-Week Double Blinded
STARTED
|
10
|
9
|
|
4-Week Double Blinded
COMPLETED
|
5
|
4
|
|
4-Week Double Blinded
NOT COMPLETED
|
5
|
5
|
|
4-Week Unblinded Treatment
STARTED
|
5
|
4
|
|
4-Week Unblinded Treatment
COMPLETED
|
4
|
3
|
|
4-Week Unblinded Treatment
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Enrollment
Lost to Follow-up
|
1
|
0
|
|
4-Week Double Blinded
Lack of Efficacy
|
0
|
1
|
|
4-Week Double Blinded
Withdrawal by Subject
|
1
|
1
|
|
4-Week Double Blinded
Lost to Follow-up
|
4
|
3
|
|
4-Week Unblinded Treatment
Adverse Event
|
1
|
0
|
|
4-Week Unblinded Treatment
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Cranial Electrotherapy Stimulation in Burned Patients
Baseline characteristics by cohort
| Measure |
A: Active/Unblinded
n=11 Participants
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
|
B: Sham/Unblinded
n=9 Participants
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
26.3 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
26.8 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Population: All active subjects
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.
Outcome measures
| Measure |
A: Active/Unblinded
n=11 Participants
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
|
B: Sham/Unblinded
n=9 Participants
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
|
Group B: BEFORE Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
Baseline
|
53.8 Score
Standard Deviation 16.4
|
56.7 Score
Standard Deviation 9.6
|
—
|
—
|
|
Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
Week 4
|
48.8 Score
Standard Deviation 15.3
|
50.4 Score
Standard Deviation 17.1
|
—
|
—
|
|
Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
Week 8
|
55.5 Score
Standard Deviation 14.8
|
44.7 Score
Standard Deviation 2.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 4 Weeks, 8 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
A: Active/Unblinded
n=10 Participants
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
|
B: Sham/Unblinded
n=9 Participants
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
|
Group B: BEFORE Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score
Baseline
|
28.8 Score
Standard Deviation 8.9
|
30.6 Score
Standard Deviation 9.9
|
—
|
—
|
|
Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score
Week 4
|
27.5 Score
Standard Deviation 8.2
|
24.5 Score
Standard Deviation 13.0
|
—
|
—
|
|
Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score
Week 8
|
36.3 Score
Standard Deviation 4.5
|
21.7 Score
Standard Deviation 9.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Population: 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.
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.
Outcome measures
| Measure |
A: Active/Unblinded
n=10 Participants
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
|
B: Sham/Unblinded
n=9 Participants
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
|
Group B: BEFORE Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
Mean Brief Profile of Mood States (BPOMS) Score
Baseline
|
50.2 Brief POMS Score
Standard Deviation 21.7
|
55.9 Brief POMS Score
Standard Deviation 15.4
|
—
|
—
|
|
Mean Brief Profile of Mood States (BPOMS) Score
Week 4
|
42.3 Brief POMS Score
Standard Deviation 21.9
|
50.3 Brief POMS Score
Standard Deviation 10.3
|
—
|
—
|
|
Mean Brief Profile of Mood States (BPOMS) Score
Week 8
|
51.0 Brief POMS Score
Standard Deviation 11.5
|
41.0 Brief POMS Score
Standard Deviation 9.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Blinded Period, Unblinded PeriodPopulation: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.
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).
Outcome measures
| Measure |
A: Active/Unblinded
n=11 Participants
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
|
B: Sham/Unblinded
n=11 Participants
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
|
Group B: BEFORE Sham or CES Treatment
n=9 Participants
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
n=9 Participants
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
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
|
3.3 VAS-P Score
Standard Deviation 1.9
|
3.9 VAS-P Score
Standard Deviation 1.5
|
4.2 VAS-P Score
Standard Deviation 1.7
|
|
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
|
2.3 VAS-P Score
Standard Deviation 1.7
|
3.3 VAS-P Score
Standard Deviation 1.4
|
2.8 VAS-P Score
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Blinded Period, Unblinded PeriodPopulation: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval
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).
Outcome measures
| Measure |
A: Active/Unblinded
n=11 Participants
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
|
B: Sham/Unblinded
n=11 Participants
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
|
Group B: BEFORE Sham or CES Treatment
n=9 Participants
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
n=9 Participants
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
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
|
3.2 VAS-A Score
Standard Deviation 2.2
|
3.3 VAS-A Score
Standard Deviation 1.7
|
3.3 VAS-A Score
Standard Deviation 1.7
|
|
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
|
2.1 VAS-A Score
Standard Deviation 1.7
|
2.8 VAS-A Score
Standard Deviation 1.1
|
2.3 VAS-A Score
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Population: All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.
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.
Outcome measures
| Measure |
A: Active/Unblinded
n=11 Participants
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
|
B: Sham/Unblinded
n=9 Participants
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
|
Group B: BEFORE Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
Group B: AFTER Sham or CES Treatment
Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
|
|---|---|---|---|---|
|
Mean General Sleep Disturbance Scale (GSDS) Score
Baseline
|
76.3 Score
Standard Deviation 22.7
|
90.8 Score
Standard Deviation 13.0
|
—
|
—
|
|
Mean General Sleep Disturbance Scale (GSDS) Score
Week 4
|
80.6 Score
Standard Deviation 16.4
|
83.3 Score
Standard Deviation 14.8
|
—
|
—
|
|
Mean General Sleep Disturbance Scale (GSDS) Score
Week 8
|
67.8 Score
Standard Deviation 30.0
|
56.3 Score
Standard Deviation 14.6
|
—
|
—
|
Adverse Events
Group A: Blinded Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group A: Unblinded Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: Blinded Phase
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B: Unblinded Phase
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Blinded Phase
n=11 participants at risk
Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
|
Group A: Unblinded Phase
n=5 participants at risk
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).
|
Group B: Blinded Phase
n=9 participants at risk
Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
|
Group B: Unblinded Phase
n=4 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Ear Pain, Tingling
|
18.2%
2/11 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 2
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/4
|
|
Psychiatric disorders
Increased Irritability
|
9.1%
1/11 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/4
|
|
Nervous system disorders
Increased Injury Site Pain
|
36.4%
4/11 • Number of events 5
|
0.00%
0/5
|
22.2%
2/9 • Number of events 16
|
25.0%
1/4 • Number of events 19
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/11
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/4
|
|
Psychiatric disorders
Night Terrors
|
9.1%
1/11 • Number of events 1
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Stiffness/ soreness
|
0.00%
0/11
|
0.00%
0/5
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Number of events 2
|
0.00%
0/5
|
0.00%
0/9
|
0.00%
0/4
|
Additional Information
LTC. Elizabeth Mann-Salinas, PhD, RN,CCRN,CCNS
U.S. Army Institute of Surgical Research
Phone: 210-916-3527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place