Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders

NCT06203717 | Completed Results FDA Device

• 1 other identifier: 2091269
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adults

Keywords

Firefighters

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)

  Post four weeks of cranial electrotherapy stimulation

• Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)

  post four weeks of cranial electrotherapy stimulation.

• Intensity of Feelings of Fatigue

  Daily throughout four weeks of cranial electrotherapy stimulation

• Intensity of Feelings of Anxiety

  Daily throughout four weeks of cranial electrotherapy stimulation

Study Arms (1)

Alpha-Stim AID cranial electrotherapy stimulation

EXPERIMENTAL

Four-week course of noninvasive cranial electrotherapy stimulation.

Device: Alpha-Stim AID cranial electrotherapy stimulation

Interventions

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.

Alpha-Stim AID cranial electrotherapy stimulation

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• University of Rhode Island: collaborator
• Brown University: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Results Point of Contact

• Title: Mascha van 't Wout-Frank
• Organization: Butler Hospital

mascha_vant_wout@brown.edu

401-680-4198

Study Officials

• Mascha van 't Wout-Frank, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: January 12, 2024
• Study Start: April 29, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)