At-home Transcranial Alternating Current Stimulation During Multitasking

The goal is to replicate in-lab results from transcranial alternating current stimulation (tACS) with at-home tACS.

Study Overview

• Status: Completed
• Conditions: Multitasking Behavior
• Intervention / Treatment: Device: Transcranial alternating current stimulation

Detailed Description

Participants will be assessed in-lab on multitasking and sustained attention abilities. Participants will be sent home with a tACS device to be used at-home for five days while engaged in a multitasking paradigm that is different from the multitasking outcome measure used pre/post tACS. After the at-home stimulation is complete, participants return to UCSF for a final in-lab assessment of multitasking and sustained attention ability.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Sandler Neurosciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speaking
• Grade 12 or more education
• Normal or corrected to normal vision and hearing
• Ability to complete cognitive tasks
• Ability to cooperate and comply with all study procedures
• Ability to tolerate tACS

Exclusion Criteria:

• Neurological or psychiatric disorders
• Family history of epilepsy
• History of seizures
• Prior head trauma
• Pregnant
• Implanted electronic devices (e.g., pacemaker)
• IQ < 80
• Taking psychotropic medication
• Taking anti-depressants or anti-anxiety medication
• Substance abuse
• Color blind
• Glaucoma
• Macular degeneration
• Amblyopia
• Strabismus

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum Stimulation; This group will receive 6-Hz tACS	Device: Transcranial alternating current stimulation; Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
Active Comparator: Frequency Control; This group will receive 1-Hz tACS	Device: Transcranial alternating current stimulation; Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multitasking Performance Cost (Neuroracer Performance Change From Baseline)	Assessment of multitasking ability using change from baseline scores in d' cost (metric of discriminability). Discrimination performance (d') was measured for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). d' cost was then calculated as the ratio of d' during single task target discrimination task to multitask target discrimination, expressed as percentage cost.	Pre-tACS and post-tACS (1 week later)
Single Task Performance Change	Discrimination performance (d') was measured during single task performance for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). Performance data was collected during the single task condition.	Pre-tACS and post-tACS (1 week later)
Multitask Performance Change	Discrimination performance (d') was measured while multitasking for each participant by comparing hit (correct responses to target signs) rates and false alarm (responses to non-targets) rates and calculated as d' = Z (hits) - Z (false alarms). Performance data was collected during the multitask condition.	Pre-tACS and post-tACS (1 week later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Performance Test RT Change (Test of Visual Attention / Sustained Attention)	Assessment of sustained attention ability using response time (in ms) during the continuous performance test	Pre-tACS and post-tACS (1 week later)
Continuous Performance Test RTV Change (Test of Visual Attention / Sustained Attention)	Assessment of sustained attention ability using response time variability (standard deviation of response times in ms) during the continuous performance test	Pre-tACS and post-tACS (1 week later)

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18-26268-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.
• IPD Sharing Time Frame: The data will be available after the results have been determined and the study researchers are unblinded. The data will be available indefinitely upon request.
• IPD Sharing Access Criteria: Contact PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No