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

NCT ID: NCT04961112

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2025-04-07

Brief Summary

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

Detailed Description

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Conditions

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Anxiety Cognitive Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
All study staff are blinded to active and sham brain stimulation devices until the completion of data collection.

Study Groups

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Experimental - Induced Anxiety

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 Type EXPERIMENTAL

Cranial Electrotherapy Stimulation

Intervention Type DEVICE

Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).

Experimental - No Induced Anxiety

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 Type EXPERIMENTAL

Cranial Electrotherapy Stimulation

Intervention Type DEVICE

Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).

Sham - Induced Anxiety

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).

Group Type SHAM_COMPARATOR

Sham Cranial Electrotherapy Stimulation

Intervention Type DEVICE

Participants will receive sham stimulation on one of two separate visits (within-subjects).

Sham - No Induced Anxiety

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 Type SHAM_COMPARATOR

Sham Cranial Electrotherapy Stimulation

Intervention Type DEVICE

Participants will receive sham stimulation on one of two separate visits (within-subjects).

Interventions

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Cranial Electrotherapy Stimulation

Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).

Intervention Type DEVICE

Sham Cranial Electrotherapy Stimulation

Participants will receive sham stimulation on one of two separate visits (within-subjects).

Intervention Type DEVICE

Other Intervention Names

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Transcranial Pulsed Current Stimulation Cranial Electrical Stimulation

Eligibility Criteria

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Inclusion Criteria

* Between 18-28 years old

Exclusion Criteria

* History of diagnosis with a neurological or psychiatric disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Nathan Ward

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tufts University

Medford, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1908026

Identifier Type: -

Identifier Source: org_study_id

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