Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits

Study Overview
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Brief Summary
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This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits

Official Title
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Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits

Conditions
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Anxiety, Cognitive Deficit

Intervention / Treatment
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* Device: Cranial Electrotherapy Stimulation
* Device: Sham Cranial Electrotherapy Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-28 years old Exclusion Criteria: History of diagnosis with a neurological or psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental - Induced Anxiety<br>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). | Device: Cranial Electrotherapy Stimulation<br>* Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).<br>* Other names: Cranial Electrical Stimulation;|
| Experimental: Experimental - No Induced Anxiety<br>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). | Device: Cranial Electrotherapy Stimulation<br>* Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).<br>* Other names: Cranial Electrical Stimulation;|
| Sham Comparator: Sham - Induced Anxiety<br>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). | Device: Sham Cranial Electrotherapy Stimulation<br>* Participants will receive sham stimulation on one of two separate visits (within-subjects).<br>|
| Sham Comparator: Sham - No Induced Anxiety<br>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). | Device: Sham Cranial Electrotherapy Stimulation<br>* Participants will receive sham stimulation on one of two separate visits (within-subjects).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task switching | Switch cost (mean switch reaction time- mean stay reaction time) | 68 weeks | 
| Working memory (N-back) | 2-back condition mean accuracy | 68 weeks | 
| Inhibition (Stroop) | Stroop interference cost (mean incongruent reaction time- mean congruent reaction time) | 68 weeks | 
| Processing speed (Simple reaction time task) | Mean reaction time | 68 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial electrotherapy stimulation, Executive functioning, Induced Anxiety, Cognition, Threat of shock, Heart rate variability