Cranial Electrotherapy Stimulation for Anxiety

N/A

Recruiting

Led By Kana Okano, Ph.D.

Research Sponsored by Tufts University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Can sit and stand freely

18-40 years of age (17-40 if emancipated minor)

Must not have

Use of prescription medications, other than oral contraceptives

History of a neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, Post-traumatic stress disorder (PTSD) or panic attacks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, at each of the 20 ces sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last ces

Summary

This trial studies how 20 sessions of Cranial Electrotherapy Stimulation (CES) affects Soldiers' biochemical, physiological, emotional and behavioral responses to stress.

Who is the study for?

This trial is for individuals aged 18-40 who have never used Cranial Electrotherapy Stimulation (CES) and can sit and stand freely. They must be willing to have their data stored for future research. People with hypertension, insomnia, brain conditions, pregnancy plans during the study, history of brain injury or illness, use of certain medications (excluding oral contraceptives), nursing mothers, or those with neurological/psychological disorders are excluded.

What is being tested?

The study tests how 20 sessions of CES affect soldiers' stress responses by measuring biochemical markers like salivary alpha amylase and cortisol, physiological indicators such as heart rate variability, emotional state anxiety levels, and cognitive task performance before and after the treatment compared to a Sham CES group.

What are the potential side effects?

While specific side effects are not detailed in this summary information provided about the clinical trial on CES for acute stress response in Soldiers; generally speaking CES may cause mild headaches or skin irritation at electrode sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can sit and stand without help.

Select...

I am between 18 and 40 years old, or 17 and emancipated.

Select...

I have never used or been treated with CES.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking prescription medications other than birth control pills.

Select...

I have a history of neurological or psychological disorders.

Select...

I have a history of heart disease or irregular heartbeats.

Select...

I have had an illness that caused brain injury.

Select...

I have had a brain-related condition in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, at each of the 20 ces sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last ces

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, at each of the 20 ces sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last ces

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at each of the 20 ces sessions completed within 4-6weeks, and at follow-up to be completed within 5 days of last ces for reporting.