Cranial Electrotherapy for Anxiety Disorders

N/A

Recruiting

Research Sponsored by Tufts University

Eligibility Criteria Checklist

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

Must have

Between 18-28 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 68 weeks

Awards & highlights

Study Summary

This trial looks at whether a device that sends electrical pulses to the brain could help people with anxiety-related cognitive problems.

Who is the study for?

This trial is for young adults aged 18-28 who experience anxiety that affects their thinking and memory. It's not suitable for those with a history of neurological or psychiatric disorders.Check my eligibility

What is being tested?

The study tests cranial electrotherapy stimulation, which uses electrical currents to potentially ease anxiety-related cognitive issues, against a sham (fake) treatment for comparison.See study design

What are the potential side effects?

Cranial electrotherapy stimulation may cause mild side effects like headache, dizziness, skin irritation at the electrode sites, and discomfort during treatment.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 28 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 68 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~68 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 68 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Inhibition (Stroop)

Processing speed (Simple reaction time task)

Task switching

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental - No Induced AnxietyExperimental Treatment1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group II: Experimental - Induced AnxietyExperimental Treatment1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group III: Sham - No Induced AnxietyPlacebo Group1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group IV: Sham - Induced AnxietyPlacebo Group1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

0 / 1Eligibility criteria met