← Back to Search

Behavioural Intervention

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)

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in decision making accuracy

Change from baseline in decision making reaction time

Change from baseline in heart rate during stressful lethal force decision making task

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active CESActive Control1 Intervention

Active Cranial Electrotherapy Stimulation (CES)

Group II: Sham CESPlacebo Group1 Intervention

Sham Cranial Electrotherapy Stimulation (CES)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts UniversityLead Sponsor

265 Previous Clinical Trials

661,703 Total Patients Enrolled

1 Trials studying Anxiety

150 Patients Enrolled for Anxiety

United States Department of DefenseFED

865 Previous Clinical Trials

327,499 Total Patients Enrolled

7 Trials studying Anxiety

1,106 Patients Enrolled for Anxiety

Kana Okano, Ph.D.Principal InvestigatorTufts University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment enlisting individuals aged 55 or older?

"To be considered for inclusion in this medical study, the patient must fall between 18 years old and 40 years old."

Answered by AI

Are there still vacancies in this research project for participants?

"Affirmative. The clinicaltrial.gov page for this study suggests that it is actively seeking participants, with the initial posting on September 13th 2023 and a recent update preceding it on September 5th. 200 patients are being recruited from one medical centre to participate in this trial."

Answered by AI

Am I eligible to enter this research program?

"This trial is seeking roughly 200 people suffering from anxiety aged 18 to 40. To be applicable, participants must meet these conditions."

Answered by AI

What is the scope of this clinical trial's participant pool?

"Affirmative. Clinicaltrials.gov has indicated that this experiment, which was initially posted on September 13th 2023, is presently searching for volunteers. 200 candidates must be scouted from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cranial Electrotherapy Stimulation and Acute Stress

2023. "Cranial Electrotherapy Stimulation and Acute Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034496.