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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this study is to quantify the effects of 20 sessions of Cranial Electrotherapy Stimulation (CES) on measures of acute stress responses in Soldiers. The main question it aims to answer is how 20 sessions of CES will affect Soldiers' biochemical (salivary alpha amylase and cortisol), physiological (e.g., heart rate, heart rate variability, respiration rate), emotional (state anxiety), and behavioral (i.e., cognitive task performance) responses.
Researchers will compare the Active CES group to the Sham CES group to see how 20 sessions of Active CES will affect the participants responses to their biochemical, physiological, emotional and behavioral responses relative to the Sham CES group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CES | Active Comparator | Active Cranial Electrotherapy Stimulation (CES) |
|
| Sham CES | Sham Comparator | Sham Cranial Electrotherapy Stimulation (CES) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active CES | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task | heart rate will be measured in beats per minute. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
| Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task | respiration rate will be measured in breaths per minute. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
| Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task | Heart rate variability will be measured in RMSSD. | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
| Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task | Cortisol (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. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
| Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task | Alpha 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. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
| Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up | STAI 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. |
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Inclusion Criteria:
Exclusion Criteria:
Use of prescription medications, other than oral contraceptives
Women only:
History of:
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| Name | Affiliation | Role |
|---|---|---|
| Kana Okano, Ph.D. | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University | Medford | Massachusetts | 02155 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40881935 | Derived | Okano K, Lee MM, Hart-Pomerantz H, Smith M, Sandone MK, Harvey T, Brunye TT. Effects of repeated cranial electrotherapy stimulation on physiological and behavioral responses to acute stress: a double-blind randomized clinical trial. Front Hum Neurosci. 2025 Aug 13;19:1641801. doi: 10.3389/fnhum.2025.1641801. eCollection 2025. |
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Participants consent to having their deidentified data placed in a repository/shared upon protocol closure, however it is not mandated by the protocol or institution.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham CES |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Heart Rate During Stressful Lethal Force Decision Making Task | heart rate will be measured in beats per minute. | Due to technical issues, we were unable to collect data from 9 participants. | Posted | Mean | Standard Deviation | bpm | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
|
1 year, 2 months
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant Professor | Center for Applied Brain and Cognitive Sciences | 617-627-1059 | kana.okano@tufts.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2023 | Aug 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2025 | May 28, 2025 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2023 | Aug 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Coded devices with master key kept outside of research team.
|
| Sham CES | Device | Sham CES group will be identical to Active CES group with the exception of the device not administering any electrical current |
|
|
| 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 CES |
| Change From Baseline in Recognition Memory | Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
| Change From Baseline in Spatial Orientation | Spatial 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. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
| Change From Baseline in Decision Making Accuracy | Participants 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. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
| Change From Baseline in Decision Making Reaction Time | 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. | Baseline and follow-up session after 20 CES completed within 4-6weeks |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| STAI-T | State Trait Anxiety Inventory - Trait version | Mean | Standard Deviation | units on a scale |
|
| Military | Count of Participants | Participants |
|
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| Primary | Change From Baseline in Respiration Rate During Stressful Lethal Force Decision Making Task | respiration rate will be measured in breaths per minute. | Posted | Mean | Standard Deviation | breath per minute | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
|
|
|
|
| Primary | Change From Baseline in Heart Rate Variability During Stressful Lethal Force Decision Making Task | Heart rate variability will be measured in RMSSD. | Posted | Mean | Standard Deviation | bpm | Baseline and follow-up session after 20 CES to be completed within 4-6weeks |
|
|
|
|
| Primary | Change Over Time in Cortisol During Stressful Lethal Force Decision Making Task | Cortisol (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. | Posted | Mean | Standard Deviation | µg/dL | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
|
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| Primary | Change Over Time in Alpha Amylase During Stressful Lethal Force Decision Making Task | Alpha 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. | Posted | Mean | Standard Deviation | IU | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
|
|
| Primary | Change Over Time in State Trait Anxiety Inventory (STAI) Scores at Each Session From Baseline to Follow-up | STAI 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. | Posted | Mean | Standard Deviation | score on a scale | 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 CES |
|
|
|
|
| Primary | Change From Baseline in Recognition Memory | Recognition memory of previously learned targets while ignoring visually similar distractor objects will be measured and evaluated with percent accuracy. | Posted | Mean | Standard Deviation | percent accuracy | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
|
|
| Primary | Change From Baseline in Spatial Orientation | Spatial 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. | Posted | Mean | Standard Deviation | absolute angle error in degrees | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
|
|
| Primary | Change From Baseline in Decision Making Accuracy | Participants 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. | Posted | Mean | Standard Deviation | d prime | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
|
|
| Primary | Change From Baseline in Decision Making Reaction Time | 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. | 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. | Posted | Baseline and follow-up session after 20 CES completed within 4-6weeks |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 2 |
| 28 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 2 | 30 |
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.
Session main effect
| Superiority |
| ANOVA | .05 | CES x Session interaction | Superiority |
Session main effect
| Superiority |
| ANOVA | .73 | CES x Session main effect | Superiority |
| Baseline 20min post |
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| Baseline 40min post |
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| Baseline 60min post |
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| Follow-up Pre |
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| Follow-up 0min post |
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| Follow-up 20min post |
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| Follow-up 40min post |
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| Follow-up 60min post |
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Time main effect
| Superiority |
| ANOVA | .53 | CES main effect | Superiority |
| ANOVA | .07 | CES x Time interaction | Superiority |
| ANOVA | .46 | CES x Session | Superiority |
| ANOVA | .01 | Time x Session interaction | Superiority |
| ANOVA | .29 | CES x Time x Session interaction | Superiority |
| Baseline 20min post |
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| Baseline 40min post |
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| Baseline 60min post |
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| Follow-up Pre |
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| Follow-up 0min post |
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| Follow-up 20min post |
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| Follow-up 40min post |
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| Follow-up 60min post |
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Time main effect
| Superiority |
| ANOVA | .81 | Session main effect | Superiority |
| ANOVA | .40 | CES x Time interaction | Superiority |
| ANOVA | .35 | CES x Session interaction | Superiority |
| ANOVA | .00 | Time x Session interaction | Superiority |
| ANOVA | .40 | CES x Time x Session interaction | Superiority |
| STAI-S Baseline Session Pre-Stress task |
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| STAI-S Baseline Session 0min Post Stress task |
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| STAI-S Baseline Session 20min Post Stress task |
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| STAI-S Baseline Session 40min Post Stress task |
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| STAI-S Baseline Session 60min Post Stress task |
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| STAI-S Follow-up Session Pre Stress task |
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| STAI-S Follow-up Session 0min Post Stress task |
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| STAI-S Follow-up Session 20min Post Stress task |
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| STAI-S Follow-up Session 40min Post Stress task |
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| STAI-S Follow-up Session 60min Post Stress task |
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STAI-T Session main effect
| Superiority |
| ANOVA | .38 | STAI-T CES x Session interaction | Superiority |
| ANOVA | .40 | STAI-S CES main effect | Superiority |
| ANOVA | .00 | STAI-S Time main effect | Superiority |
| ANOVA | .00 | STAI-S Session main effect | Superiority |
| ANOVA | .20 | STAI-S CES x Time interaction | Superiority |
| ANOVA | .39 | STAI-S CES x Session interaction | Superiority |
| ANOVA | .00 | STAI-S Session x Time interaction | Superiority |
| ANOVA | .38 | STAI-S CES x Time x Session interaction | Superiority |
Session main effect
| Superiority |
| ANOVA | .4 | CES x Session interaction | Superiority |
Session main effect
| Superiority |
| ANOVA | .44 | CES x Session interaction | Superiority |
Session main effect
| Superiority |
| ANOVA | .96 | CES x Session interaction | Superiority |