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| Name | Class |
|---|---|
| University of Rhode Island | OTHER |
| Brown University | OTHER |
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The goal of this study is to test whether active duty firefighters find it possible and suitable to do cranial electrotherapy stimulation (CES) at home, and test whether CES influences measures of depression and posttraumatic stress. The main questions it aims to answer are:
Participants will
Despite an urgent need for interventions that can prevent the development of posttraumatic stress disorder (PTSD) in firefighter first responders who, due to the nature of their occupation, are at ultrahigh risk for PTSD and its profound consequences, current preventative approaches suffer from low rates of efficacy or difficulties with implementation. Cranial electrotherapy stimulation (CES), a noninvasive brain stimulation technique that is FDA approved for treatment of anxiety, insomnia, and depression, offers substantial promise as a proactive preventative intervention for PTSD because of its hypothesized ability to reestablish homeostasis, a process that becomes dysregulated in individuals who develop PTSD. The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct Centers of Biomedical Research Excellence to test whether four weeks of CES is feasible and acceptable in firefighters as well as obtain early signal of CES efficacy to change subjective and objective indices of homeostatic functioning to allow a long-term collaboration with the ultimate goal to develop a safe, effective, and easily deployable intervention to prevent PTSD in first responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Experimental | Four-week course of noninvasive cranial electrotherapy stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Device | Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Cranial Electrotherapy Stimulation | Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed). | During four weeks of cranial electrotherapy stimulation at-home use |
| Acceptability of Cranial Electrotherapy Stimulation | Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks | During four weeks of cranial electrotherapy stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5) | Score on the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms. | Post four weeks of cranial electrotherapy stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mascha van 't Wout-Frank, PhD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alpha-Stim AID cranial electrotherapy stimulation | Four-week course of noninvasive cranial electrotherapy stimulation. Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alpha-Stim AID cranial electrotherapy stimulation | Four-week course of noninvasive cranial electrotherapy stimulation. Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days. |
| 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 | Feasibility of Cranial Electrotherapy Stimulation | Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed). | Posted | Mean | Standard Deviation | percentage of CES sessions completed | During four weeks of cranial electrotherapy stimulation at-home use |
|
Weekly during the one month of at home cranial electrotherapy stimulation
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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 | Alpha-Stim AID cranial electrotherapy stimulation | Four-week course of noninvasive cranial electrotherapy stimulation. Alpha-Stim AID cranial electrotherapy stimulation: Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment | Tingling, itchy feeling under electrodes attached to ears |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mascha van 't Wout-Frank | Butler Hospital | 401-680-4198 | mascha_vant_wout@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2024 | Oct 7, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2025 | Oct 7, 2025 | ICF_001.pdf |
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| Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR) |
Score on the Inventory of Depressive Symptomatology-Self Report (IDS-SR). The Inventory of Depressive Symptomatology-Self Report (IDS-SR) has a total score range of 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology. |
| post four weeks of cranial electrotherapy stimulation. |
| Intensity of Feelings of Fatigue | Intensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale. | Daily throughout four weeks of cranial electrotherapy stimulation |
| Intensity of Feelings of Anxiety | Intensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale. | Daily throughout four weeks of cranial electrotherapy stimulation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 | Severity of posttraumatic stress symptoms as measured with the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms. | Number | score on PTSD Checklist for DSM-5 |
|
| Inventory of Depressive Symptomatology-Self Report (IDS-SR). | Presence and severity of depression symptoms assessed using the Inventory of Depressive Symptomatology-Self Report (IDS-SR). Score ranges from 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology. | Mean | Standard Deviation | score on IDS-SR |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Primary | Acceptability of Cranial Electrotherapy Stimulation | Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks | Posted | Count of Participants | Participants | During four weeks of cranial electrotherapy stimulation |
|
|
|
| Secondary | Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5) | Score on the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms. | Posted | Mean | Standard Deviation | score on PTSD Checklist for DSM-5 | Post four weeks of cranial electrotherapy stimulation |
|
|
|
|
| Secondary | Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR) | Score on the Inventory of Depressive Symptomatology-Self Report (IDS-SR). The Inventory of Depressive Symptomatology-Self Report (IDS-SR) has a total score range of 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology. | Posted | Mean | Standard Deviation | score on Inventory of Depressive Symptom | post four weeks of cranial electrotherapy stimulation. |
|
|
|
|
| Secondary | Intensity of Feelings of Fatigue | Intensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale. | Not Posted | Daily throughout four weeks of cranial electrotherapy stimulation | Participants |
| Secondary | Intensity of Feelings of Anxiety | Intensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale. | Not Posted | Daily throughout four weeks of cranial electrotherapy stimulation | Participants |
| 0 |
| 13 |
| 0 |
| 13 |
| 9 |
| 13 |
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| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment | Temporary skin redness under electrodes attached to ears |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ringing in ears | Ear and labyrinth disorders | Systematic Assessment |
|
| Mood changes | Psychiatric disorders | Systematic Assessment |
|
| Difficulties concentrating | Nervous system disorders | Systematic Assessment |
|
| Feeling drowsy | Nervous system disorders | Systematic Assessment |
|
| Phosphenes | Nervous system disorders | Systematic Assessment | Experience of brief flickering lights |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Nervous system disorders | Systematic Assessment |
|
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