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

Primary Purpose

Anxiety, Cognitive Deficit

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cranial Electrotherapy Stimulation

Sham Cranial Electrotherapy Stimulation

About this trial

This is an interventional basic science trial for Anxiety focused on measuring Cranial electrotherapy stimulation, Executive functioning, Induced Anxiety, Cognition, Threat of shock, Heart rate variability

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Between 18-28 years old

Exclusion Criteria:

History of diagnosis with a neurological or psychiatric disorder.

Sites / Locations

Tufts UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental - Induced Anxiety

Experimental - No Induced Anxiety

Sham - Induced Anxiety

Sham - No Induced Anxiety

Arm 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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Task switching

Switch cost (mean switch reaction time- mean stay reaction time)

Working memory (N-back)

2-back condition mean accuracy

Inhibition (Stroop)

Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)

Processing speed (Simple reaction time task)

Mean reaction time

Secondary Outcome Measures

Full Information

NCT ID

NCT04961112

First Posted

July 1, 2021

Last Updated

March 7, 2023

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT04961112

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 6, 2021 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Cognitive Deficit

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental - Induced Anxiety

Arm Type

Experimental

Arm Description

Arm Title

Experimental - No Induced Anxiety

Arm Type

Experimental

Arm 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).

Arm Title

Sham - Induced Anxiety

Arm Type

Sham Comparator

Arm 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).

Arm Title

Sham - No Induced Anxiety

Arm Type

Sham Comparator

Arm 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).

Intervention Type

Device

Intervention Name(s)

Cranial Electrotherapy Stimulation

Other Intervention Name(s)

Transcranial Pulsed Current Stimulation, Cranial Electrical Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham Cranial Electrotherapy Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Task switching

Description

Switch cost (mean switch reaction time- mean stay reaction time)

Time Frame

68 weeks

Title

Working memory (N-back)

Description

2-back condition mean accuracy

Time Frame

68 weeks

Title

Inhibition (Stroop)

Description

Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)

Time Frame

68 weeks

Title

Processing speed (Simple reaction time task)

Description

Mean reaction time

Time Frame

68 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

28 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nathan Ward, PhD

Phone

6176272645

nathan.ward@tufts.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Wooten, BS

Phone

5088383583

thomas.wooten@tufts.edu

Facility Information:

Facility Name

Tufts University

City

Medford

State/Province

Massachusetts

ZIP/Postal Code

02155

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathan Ward

nathan.ward@tufts.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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