Cranial Electrotherapy for PTSD Prevention

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Neurological conditions, Suicidal ideation, Psychiatric hospitalization, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether firefighters can use a cranial electrotherapy device at home to reduce stress, fatigue, and anxiety. It also explores the device's effects on brain activity and connections. Participants will use the device for four weeks, track their stress and anxiety daily, and may undergo MRI scans and wear a device to monitor heart rate and sleep. Firefighters in Rhode Island with stable health conditions are well-suited for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance stress management tools for firefighters.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cranial electrotherapy stimulation is safe for firefighters?

Research has shown that the Alpha-Stim AID device, which uses cranial electrotherapy stimulation (CES), is very safe. Studies have found no serious side effects. Some minor symptoms might occur, but they are not serious. The device is already used to treat anxiety and insomnia, indicating that most people tolerate it well. Overall, CES is a non-invasive treatment, meaning it doesn't involve surgery and is gentle on the body. This makes it a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for PTSD, which often involve medications like SSRIs or therapy, the Alpha-Stim AID cranial electrotherapy stimulation is a noninvasive approach that uses small electrical currents to influence brain activity. This method is unique because it aims to prevent PTSD symptoms before they fully develop, rather than just treating existing symptoms. Researchers are excited about its potential to offer a quicker, drug-free alternative that may have fewer side effects compared to traditional medication-based therapies.

What evidence suggests that cranial electrotherapy stimulation is effective for stress in firefighters?

Research has shown that cranial electrotherapy stimulation (CES), which participants in this trial will receive, can help reduce anxiety and depression symptoms. A review of several studies found CES effective for treating anxiety, depression, and sleep disturbances. Another study showed that CES improved anxiety and depression in people with generalized anxiety disorder. These findings suggest CES could help manage stress and anxiety, common issues for firefighters. While more research is needed, early results are promising for CES as a tool for mental health support. ^{4 5 6 7 8}

Who Is on the Research Team?

Mascha van 't Wout-Frank, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

This trial is for adult firefighters who are interested in trying a home-based treatment to manage stress. They should be willing to use the Alpha-Stim AID device daily, track their fatigue and anxiety levels, possibly undergo MRI scans, and wear a heart rate and sleep quality monitor.

Inclusion Criteria

I am in good health or my chronic conditions are stable.

Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent

Active duty firefighter in Rhode Island, USA

Exclusion Criteria

I have not had brain-related health issues like tumors, strokes, seizures, dementia, or brain surgery.

I need hospital care for my mental health condition.

Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete four weeks of cranial electrotherapy stimulation (CES) at home, with daily assessments of fatigue and anxiety, and may undergo MRI scans before and after CES.

4 weeks

Daily self-assessments, 2 MRI visits (pre and post-treatment)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PTSD symptoms.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alpha-Stim AID cranial electrotherapy stimulation

Trial Overview The study is testing if using the Alpha-Stim AID cranial electrotherapy stimulation device at home is doable and helpful for firefighters. It looks at how this treatment might affect their stress levels by measuring changes in fatigue, anxiety, brain function, heart rate, and sleep quality over four weeks.

How Is the Trial Designed?

Group I: Alpha-Stim AID cranial electrotherapy stimulation Experimental Treatment 1 Intervention

Four-week course of noninvasive cranial electrotherapy stimulation.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

Brown University

Collaborator

Trials

480

Recruited

724,000+

University of Rhode Island

Collaborator

Trials

57

Recruited

22,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03757494

Cranial Electrotherapy Stimulation in the Treatment of ... This is a research study that will look at how well a treatment called Cranial Electrotherapy Stimulation (CES) works for patients who struggle with symptoms of ...

2. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/CES.pdf

The Effectiveness and Risks of Cranial Electrical Stimulation ... The Effectiveness and Risks of Cranial Electrical Stimulation for the Treatment of Pain,. Depression, Anxiety, PTSD, and Insomnia: A Systematic Review. VA ESP ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882621/

A Critical Review of Cranial Electrotherapy Stimulation for ... A recent open consecutive cohort study demonstrated improvement in anxiety and depression symptoms of generalized anxiety order following 12 and ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1157473/full

Efficacy of electrical cranial stimulation for treatment ... This meta-analysis aimed at investigating acceptability and therapeutic efficacy of CES against anxiety, depression, and insomnia for patients who experienced ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06203717

Cranial Electrotherapy Stimulation: Piloting a Road to ... The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493135/

The Effectiveness and Risks of Cranial Electrical Stimulation ... We judged the quality of evidence for the conclusion that CES does not cause serious adverse events but does cause certain minor symptoms as low, downgraded ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468171722000060

Cranial electrotherapy stimulation for PTSD: feasibility, safety Alpha-Stim® showed an excellent safety profile with no adverse effects. The results suggest preliminary efficacy for improving PTSD symptoms as well as ...

8. alpha-stim.com alpha-stim.com/indications-and-risks/?srsltid=AfmBOorevW2B8ruhIYwRlil9DBGvwiGFg4U3bzYiAFksZCek_jTfV3r_

Indications and Risks The Alpha-Stim AID is a precision medical device used for cranial electrotherapy stimulation for the treatment of anxiety and insomnia.