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

NCT04961112 | Completed

• 1 other identifier: 1908026
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Cognitive Deficit

Keywords

Cranial electrotherapy stimulation; Executive functioning; Induced Anxiety; Cognition; Threat of shock; Heart rate variability

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Experimental - Induced Anxiety

EXPERIMENTAL

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

Experimental - No Induced Anxiety

EXPERIMENTAL

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

Sham - Induced Anxiety

SHAM COMPARATOR

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

Sham - No Induced Anxiety

SHAM COMPARATOR

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

Interventions

Cranial Electrotherapy Stimulation DEVICE

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

Also known as: Transcranial Pulsed Current Stimulation, Cranial Electrical Stimulation

Experimental - Induced Anxiety; Experimental - No Induced Anxiety

Sham Cranial Electrotherapy Stimulation DEVICE

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

Sham - Induced Anxiety; Sham - No Induced Anxiety

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-28 years old

You may not qualify if:

• History of diagnosis with a neurological or psychiatric disorder.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University

Medford, Massachusetts, 02155, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Cognition Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study staff are blinded to active and sham brain stimulation devices until the completion of data collection.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 14, 2021
• Study Start: September 6, 2021
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)