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

Not Applicable

Active, not recruiting

• Conditions: Anxiety; Cognitive Deficit
• Interventions: Device: Cranial Electrotherapy Stimulation; Device: Sham Cranial Electrotherapy Stimulation

• Registration Number: NCT04961112
• Lead Sponsor: Tufts University

Brief Summary

This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-14
• Study Start: 2021-09-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Between 18-28 years old

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Exclusion Criteria

• History of diagnosis with a neurological or psychiatric disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental - No Induced Anxiety	Cranial Electrotherapy Stimulation	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).
Experimental - Induced Anxiety	Cranial Electrotherapy Stimulation	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).
Sham - Induced Anxiety	Sham Cranial Electrotherapy Stimulation	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).
Sham - No Induced Anxiety	Sham Cranial Electrotherapy Stimulation	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tufts University; 🇺🇸 Medford, Massachusetts, United States