N/A
N=13
Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
Adults
Bottom Line
View on ClinicalTrials.gov: NCT06203717 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Feasibility of Cranial Electrotherapy Stimulation — 86.15 percentage of CES sessions completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alpha-Stim AID cranial electrotherapy stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Cranial Electrotherapy Stimulation |
86.15 | — |
| PRIMARY Acceptability of Cranial Electrotherapy Stimulation |
10 | — |
| SECONDARY Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5) |
10.85 | 0.007 sig |
| SECONDARY Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR) |
11.00 | 0.0009 sig |
| SECONDARY Intensity of Feelings of Fatigue |
— | — |
| SECONDARY Intensity of Feelings of Anxiety |
— | — |
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. The main questions it aims to answer are:
* is CES feasible and acceptable in a population of firefighters, and
* does CES changes feelings of depression, 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06203717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.