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

March 7, 2023 updated by: Nathan Ward, Tufts University
This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18-28 years old

Exclusion Criteria:

  • History of diagnosis with a neurological or psychiatric disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: Cranial Electrotherapy Stimulation
Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).
Other Names:
  • Transcranial Pulsed Current Stimulation
  • Cranial Electrical Stimulation
Experimental: 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).
Device: Cranial Electrotherapy Stimulation
Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).
Other Names:
  • Transcranial Pulsed Current Stimulation
  • Cranial Electrical Stimulation
Sham Comparator: 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).
Device: Sham Cranial Electrotherapy Stimulation
Participants will receive sham stimulation on one of two separate visits (within-subjects).
Sham Comparator: 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).
Device: Sham Cranial Electrotherapy Stimulation
Participants will receive sham stimulation on one of two separate visits (within-subjects).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1908026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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