AdultsNCT06203717
Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
A study testing Alpha-Stim AID cranial electrotherapy stimulation in people with Adults and Firefighters, run by Butler Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults, Firefighters
- What is being tested?
- Alpha-Stim AID cranial electrotherapy stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active duty firefighter in Rhode Island, USA;
- Age between 18 and 56 years old;
- Be in good medical health or, if having chronic medical conditions, these conditions needed to be stable;
- Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent.
Who cannot join
- MRI and CES-related contraindications, e.g., implanted metallic device or substances including pacemakers, cochlear implant, metallic tattoos, claustrophobia, pregnancy or planning to become pregnant during the study duration and nursing;
- Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery;
- Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months;
- Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization;
- Current moderate or severe alcohol or other substance abuse (excluding nicotine);
- Major or unstable medical illness requiring further investigation or treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- is CES feasible and acceptable in a population of firefighters, and
- does CES changes symptoms of posttraumatic stress and depression as well as feelings of anxiety, and fatigue in firefighters.
Read more
Participants will
- complete four weeks of CES at home, and
- complete daily assessments of affect and fatigue, and
- complete self-reported symptoms of depression and posttraumatic stress before and after four weeks of CES at home Participants maybe asked to
- complete an MRI scan before and after four weeks of CES at, and
- wear a device to measure their heart rate and sleep quality.
Read the detailed description
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.
- Conditions
- Adults, Firefighters
- Being tested
- Alpha-Stim AID cranial electrotherapy stimulation
- Keywords
- Firefighters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Stim AID cranial electrotherapy stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Experimental | Four-week course of noninvasive cranial electrotherapy stimulation. Receives: Device: Alpha-Stim AID cranial electrotherapy stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: During four weeks of cranial electrotherapy stimulation
Secondary outcomes (4)
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.
Measured: Post four weeks of cranial electrotherapy stimulation
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.
Measured: 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.
Measured: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Intensity of Feelings of Anxiety
Intensity of subjective anxiety assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Measured: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start29 Apr 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island, Brown University
- Responsible party
- Sponsor
- Investigators
- Mascha van 't Wout-Frank, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203717
- Sponsor's protocol ID
- 2091269
- Status last verified
- Oct 2025
- First submitted
- 8 Nov 2023
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
- ClinicalTrials.gov ID
- NCT06203717
- Acronym / sponsor ID
- 2091269
- Conditions
- Adults, Firefighters
- Keywords
- Firefighters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- University of Rhode Island, Brown University
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- is CES feasible and acceptable in a population of firefighters, and
- does CES changes symptoms of posttraumatic stress and depression as well as feelings of anxiety, and fatigue in firefighters.
Participants will
- complete four weeks of CES at home, and
- complete daily assessments of affect and fatigue, and
- complete self-reported symptoms of depression and posttraumatic stress before and after four weeks of CES at home Participants maybe asked to
- complete an MRI scan before and after four weeks of CES at, and
- wear a device to measure their heart rate and sleep quality.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Experimental | Device: Alpha-Stim AID cranial electrotherapy stimulationFour-week course of noninvasive cranial electrotherapy stimulation. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active duty firefighter in Rhode Island, USA;
- Age between 18 and 56 years old;
- Be in good medical health or, if having chronic medical conditions, these conditions needed to be stable;
- Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent.
Key exclusion criteria (6 listed)
- MRI and CES-related contraindications, e.g., implanted metallic device or substances including pacemakers, cochlear implant, metallic tattoos, claustrophobia, pregnancy or planning to become pregnant during the study duration and nursing;
- Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery;
- Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months;
- Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization;
- Current moderate or severe alcohol or other substance abuse (excluding nicotine);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulationCranial 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. | Device | Alpha-Stim AID cranial electrotherapy stimulation |
Primary outcome
Feasibility of Cranial Electrotherapy Stimulation
Time frame: During four weeks of cranial electrotherapy stimulation at-home use
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).
Acceptability of Cranial Electrotherapy Stimulation
Time frame: During four weeks of cranial electrotherapy stimulation
Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks
4 secondary outcomes
Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)
Time frame: Post four weeks of cranial electrotherapy stimulation
Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Time frame: post four weeks of cranial electrotherapy stimulation.
Intensity of Feelings of Fatigue
Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Intensity of Feelings of Anxiety
Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mascha van 't Wout-Frank, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Stim AID cranial electrotherapy stimulation in people with Adults and Firefighters, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Cranial Electrotherapy Stimulation (time frame: During four weeks of cranial electrotherapy stimulation at-home use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.