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

Tufts University

Status: Completed

Conditions: Cognitive Deficit; Anxiety

Treatments: Device: Sham Cranial Electrotherapy Stimulation; Device: Cranial Electrotherapy Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04961112

1908026

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 18-28 years old

Exclusion criteria

• History of diagnosis with a neurological or psychiatric disorder.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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124 participants in 4 patient groups

Experimental - Induced Anxiety

Experimental group

Description:

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).

Treatment:

Device: Cranial Electrotherapy Stimulation

Experimental - No Induced Anxiety

Experimental group

Description:

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).

Treatment:

Device: Cranial Electrotherapy Stimulation

Sham - Induced Anxiety

Sham Comparator group

Description:

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).

Treatment:

Device: Sham Cranial Electrotherapy Stimulation

Sham - No Induced Anxiety

Sham Comparator group

Description:

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).

Treatment:

Device: Sham Cranial Electrotherapy Stimulation