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

Sponsor

Tufts University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04961112

Collaborator

(none)

150

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Cognitive Deficit	Device: Cranial Electrotherapy Stimulation Device: Sham Cranial Electrotherapy Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 6, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

Task switching [68 weeks]
Switch cost (mean switch reaction time- mean stay reaction time)
Working memory (N-back) [68 weeks]
2-back condition mean accuracy
Inhibition (Stroop) [68 weeks]
Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)
Processing speed (Simple reaction time task) [68 weeks]
Mean reaction time