Trial Outcomes & Findings for Cranial Electrotherapy Stimulation and Acute Stress (NCT NCT06034496)
NCT ID: NCT06034496
Last Updated: 2025-09-15
Results Overview
heart rate will be measured in beats per minute.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Baseline and follow-up session after 20 CES to be completed within 4-6weeks
Results posted on
2025-09-15
Participant Flow
76 participants consented to participate in the study. However, 18 participants (soldiers) were unable to start the study due to scheduling conflicts. Therefore, only 58 are included in the Participant Flow.
Participant milestones
| Measure |
Active CES
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Active CES
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Overall Study
Did not meet minimum stimulation threshold
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Cranial Electrotherapy Stimulation and Acute Stress
Baseline characteristics by cohort
| Measure |
Active CES
n=21 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=25 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.95 years
STANDARD_DEVIATION 2.94 • n=5 Participants
|
23.36 years
STANDARD_DEVIATION 5.82 • n=7 Participants
|
22.26 years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Education
|
13.95 years
STANDARD_DEVIATION 1.43 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 3.04 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 2.44 • n=5 Participants
|
|
STAI-T
|
33.71 units on a scale
STANDARD_DEVIATION 10.75 • n=5 Participants
|
29.52 units on a scale
STANDARD_DEVIATION 7.28 • n=7 Participants
|
31.43 units on a scale
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Military
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES to be completed within 4-6weeksPopulation: Due to technical issues, we were unable to collect data from 9 participants.
heart rate will be measured in beats per minute.
Outcome measures
| Measure |
Active CES
n=18 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=19 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task
Baseline
|
98.5 bpm
Standard Deviation 16.1
|
111 bpm
Standard Deviation 19.5
|
|
Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task
Follow-up
|
100.0 bpm
Standard Deviation 13.5
|
114 bpm
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES to be completed within 4-6weeksrespiration rate will be measured in breaths per minute.
Outcome measures
| Measure |
Active CES
n=18 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=19 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task
Baseline
|
16.2 breath per minute
Standard Deviation 3.52
|
17.7 breath per minute
Standard Deviation 3.53
|
|
Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task
Follow-up
|
17.3 breath per minute
Standard Deviation 3.05
|
16.8 breath per minute
Standard Deviation 3.22
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES to be completed within 4-6weeksHeart rate variability will be measured in RMSSD.
Outcome measures
| Measure |
Active CES
n=18 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=19 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task
Baseline
|
13.0 bpm
Standard Deviation 5.17
|
11.2 bpm
Standard Deviation 4.53
|
|
Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task
Follow-up
|
12.0 bpm
Standard Deviation 4.76
|
10.5 bpm
Standard Deviation 4.74
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksCortisol (µg/dL) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.
Outcome measures
| Measure |
Active CES
n=21 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=25 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Baseline Pre
|
.293 µg/dL
Standard Deviation .137
|
.415 µg/dL
Standard Deviation .183
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Baseline 0min post
|
.54 µg/dL
Standard Deviation .36
|
.399 µg/dL
Standard Deviation .105
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Baseline 20min post
|
.57 µg/dL
Standard Deviation .396
|
.655 µg/dL
Standard Deviation .476
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Baseline 40min post
|
.371 µg/dL
Standard Deviation .194
|
.456 µg/dL
Standard Deviation .252
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Baseline 60min post
|
.29 µg/dL
Standard Deviation .156
|
.369 µg/dL
Standard Deviation .197
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Follow-up Pre
|
.335 µg/dL
Standard Deviation .149
|
.345 µg/dL
Standard Deviation .123
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Follow-up 0min post
|
.644 µg/dL
Standard Deviation .433
|
.556 µg/dL
Standard Deviation .296
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Follow-up 20min post
|
.444 µg/dL
Standard Deviation .206
|
.534 µg/dL
Standard Deviation .292
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Follow-up 40min post
|
.407 µg/dL
Standard Deviation .268
|
.417 µg/dL
Standard Deviation .163
|
|
Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task
Follow-up 60min post
|
.335 µg/dL
Standard Deviation .198
|
.379 µg/dL
Standard Deviation .171
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksAlpha amylase (IU) will be measured through saliva samples. Saliva samples will be taken at five time points, approximately 20 minute increments during the baseline and follow-up sessions.
Outcome measures
| Measure |
Active CES
n=21 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=24 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Follow-up 20min post
|
110 IU
Standard Deviation 71.8
|
90.8 IU
Standard Deviation 72.6
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Follow-up 60min post
|
128 IU
Standard Deviation 84.9
|
97.5 IU
Standard Deviation 91.7
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Baseline Pre
|
118 IU
Standard Deviation 90.6
|
79.1 IU
Standard Deviation 69.2
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Baseline 0min post
|
144 IU
Standard Deviation 91.3
|
131 IU
Standard Deviation 121
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Baseline 20min post
|
88.6 IU
Standard Deviation 50.6
|
84 IU
Standard Deviation 61
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Baseline 40min post
|
110 IU
Standard Deviation 87.6
|
78.1 IU
Standard Deviation 58.2
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Baseline 60min post
|
105 IU
Standard Deviation 66.2
|
79.8 IU
Standard Deviation 61.2
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Follow-up Pre
|
68.4 IU
Standard Deviation 51.0
|
61.7 IU
Standard Deviation 48.6
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Follow-up 0min post
|
99.8 IU
Standard Deviation 39.3
|
129 IU
Standard Deviation 101
|
|
Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task
Follow-up 40min post
|
91.2 IU
Standard Deviation 49.5
|
92.6 IU
Standard Deviation 78.6
|
PRIMARY outcome
Timeframe: At baseline, at each of the 20 CES sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last CESSTAI assesses both state and trait anxiety separately with each scale ranging from 20 to 80, with higher scores correlating with greater anxiety. STAI-S is the State Trait Anxiety Inventory - State version, and STAI-T is the State Trait Anxiety Inventory - Trait version.
Outcome measures
| Measure |
Active CES
n=21 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=25 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAT-T at baseline Pre CES intervention
|
33.71 score on a scale
Standard Deviation 10.75
|
29.52 score on a scale
Standard Deviation 7.28
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAT-T at follow-up Post CES intervention
|
33.33 score on a scale
Standard Deviation 12.72
|
32.64 score on a scale
Standard Deviation 7.16
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Baseline Session Pre-Stress task
|
33.4 score on a scale
Standard Deviation 7.94
|
31.0 score on a scale
Standard Deviation 6.62
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Baseline Session 0min Post Stress task
|
39.5 score on a scale
Standard Deviation 10.7
|
41.6 score on a scale
Standard Deviation 12.2
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Baseline Session 20min Post Stress task
|
35.6 score on a scale
Standard Deviation 11.5
|
34.1 score on a scale
Standard Deviation 9.53
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Baseline Session 40min Post Stress task
|
32.4 score on a scale
Standard Deviation 9.79
|
30.6 score on a scale
Standard Deviation 8.54
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Baseline Session 60min Post Stress task
|
30.9 score on a scale
Standard Deviation 9.56
|
29.1 score on a scale
Standard Deviation 6.66
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Follow-up Session Pre Stress task
|
33.8 score on a scale
Standard Deviation 15.0
|
27.6 score on a scale
Standard Deviation 8.55
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Follow-up Session 0min Post Stress task
|
34.6 score on a scale
Standard Deviation 12.0
|
33.0 score on a scale
Standard Deviation 10.8
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Follow-up Session 20min Post Stress task
|
30.4 score on a scale
Standard Deviation 11.6
|
29.3 score on a scale
Standard Deviation 8.55
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Follow-up Session 40min Post Stress task
|
29.0 score on a scale
Standard Deviation 9.95
|
26.6 score on a scale
Standard Deviation 7.94
|
|
Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up
STAI-S Follow-up Session 60min Post Stress task
|
29.1 score on a scale
Standard Deviation 9.75
|
26.1 score on a scale
Standard Deviation 8.13
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksRecognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy.
Outcome measures
| Measure |
Active CES
n=17 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=21 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Recognition Memory
Baseline
|
77.1 percent accuracy
Standard Deviation 11
|
80 percent accuracy
Standard Deviation 12.2
|
|
Change From Baseline in Recognition Memory
Follow-up
|
78.2 percent accuracy
Standard Deviation 15.9
|
76.7 percent accuracy
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksSpatial orientation task will involve pointing towards a series of distant (out of visible range) landmarks in the virtual environment and estimating distance to those landmarks. Spatial orientation will be calculated using mean absolute angular error. Larger numbers correlate with higher error.
Outcome measures
| Measure |
Active CES
n=19 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=21 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Spatial Orientation
Baseline
|
20.7 absolute angle error in degrees
Standard Deviation 8.12
|
18.8 absolute angle error in degrees
Standard Deviation 10.4
|
|
Change From Baseline in Spatial Orientation
Follow-up
|
21.2 absolute angle error in degrees
Standard Deviation 12.7
|
16.3 absolute angle error in degrees
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksParticipants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making accuracy will be calculated using d prime. Higher d prime correlates with better accuracy.
Outcome measures
| Measure |
Active CES
n=17 Participants
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=20 Participants
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
Change From Baseline in Decision Making Accuracy
Baseline
|
3.64 d prime
Standard Deviation .681
|
3.89 d prime
Standard Deviation 1.08
|
|
Change From Baseline in Decision Making Accuracy
Follow-up
|
4.48 d prime
Standard Deviation .943
|
4.75 d prime
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Baseline and follow-up session after 20 CES completed within 4-6weeksPopulation: Collected data were invalid and could not be analyzed due to a coding error. The coding error incorrectly summed and aggregated the distances of all avatars on the screen, rather than isolating the distance of the specific avatar that was shot. As a result, we were unable to reverse engineer the output to derive a value that accurately reflected Reaction Times.
Participants will make lethal force decision making by shooting at threatening targets and allowing non-threatening targets to pass. Decision making reaction time to shoot at threatening targets will be measured in milliseconds.
Outcome measures
Outcome data not reported
Adverse Events
Active CES
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham CES
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active CES
n=28 participants at risk
Active Cranial Electrotherapy Stimulation (CES)
Active CES: Active CES group will receive a minimum of 250µA and up to 500µA depending on thresholding, once daily for 20 days (over the course of 4\~6 weeks), 20 minutes per day.
|
Sham CES
n=30 participants at risk
Sham Cranial Electrotherapy Stimulation (CES)
Sham CES: Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current
|
|---|---|---|
|
General disorders
Dizziness
|
7.1%
2/28 • 1 year, 2 months
|
6.7%
2/30 • 1 year, 2 months
|
Additional Information
Research Assistant Professor
Center for Applied Brain and Cognitive Sciences
Phone: 617-627-1059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee This research is funded by the U.S. Special Operations Command (SOCOM). Disclosure of research findings is subject to government operational security (OPSEC) and Public Affairs Office (PAO) review processes, in accordance with DoD Directives 5205.02E and 5230.29. As such, the Principal Investigator's ability to publicly disseminate or discuss trial results following study completion is restricted until appropriate clearances are obtained.
- Publication restrictions are in place
Restriction type: OTHER