Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Processing speed (Simple reaction time task)
Study Overview
Brief Summary
This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- 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.
Eligibility Criteria
- Ages
- 18 Years to 28 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Between 18-28 years old
Exclusion Criteria
- •History of diagnosis with a neurological or psychiatric disorder.
Arms & Interventions
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).
Intervention: Cranial Electrotherapy Stimulation (Device)
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).
Intervention: Cranial Electrotherapy Stimulation (Device)
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).
Intervention: Sham Cranial Electrotherapy Stimulation (Device)
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).
Intervention: Sham Cranial Electrotherapy Stimulation (Device)
Outcomes
Primary Outcomes
Processing speed (Simple reaction time task)
Time Frame: 68 weeks
Mean reaction time
Task switching
Time Frame: 68 weeks
Switch cost (mean switch reaction time- mean stay reaction time)
Working memory (N-back)
Time Frame: 68 weeks
2-back condition mean accuracy
Inhibition (Stroop)
Time Frame: 68 weeks
Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)
Secondary Outcomes
No secondary outcomes reported
Investigators
Nathan Ward
Associate Professor
Tufts University