Multitasking BehaviorNCT04231825

At-home Transcranial Alternating Current Stimulation During Multitasking

A study testing Transcranial alternating current stimulation in people with Multitasking Behavior, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Multitasking Behavior
What is being tested?: Transcranial alternating current stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2019to 15 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Neurological or psychiatric disorders
Family history of epilepsy
History of seizures
Prior head trauma
Pregnant
Implanted electronic devices (e.g., pacemaker)

Show all 15Show fewer

IQ < 80
Taking psychotropic medication
Taking anti-depressants or anti-anxiety medication
Substance abuse
Color blind
Glaucoma
Macular degeneration
Amblyopia
Strabismus

Trial locations and contacts

1 site in 1 country.

United States1 site

Sandler Neurosciences Center
San Francisco, California, 94158

Other trials in United States

About this study

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

Read the 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.

Conditions: Multitasking Behavior
Being tested: Transcranial alternating current stimulation
Medical subject headings: Multitasking Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial alternating current stimulationDevice
Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.

Study groups in NCT04231825
Study group	Role	What they receive
Verum Stimulation	Experimental	This group will receive 6-Hz tACS Receives: Device: Transcranial alternating current stimulation
Frequency Control	Active comparator	This group will receive 1-Hz tACS Receives: Device: Transcranial alternating current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Pre-tACS and post-tACS (1 week later)

Secondary outcomes (2)

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
Measured: 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
Measured: Pre-tACS and post-tACS (1 week later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201915 Sep 2020

First posted18 Jan 2020
Study start15 Oct 2019
Primary completion15 Aug 2020
Study completion15 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multitasking BehaviorStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04231825
Sponsor's protocol ID: 18-26268-1
Status last verified: Mar 2022
First submitted: 8 Oct 2019
Last updated: 21 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Clinical Performance and Multitasking in Anesthesia : a Simulation-based Study
Multitasking Behavior and Multitasking Ability, Clinical Performance
Recruiting
Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults
Stress Response, Mental Stress
Recruiting
MultiCPR: The Influence of Resuscitation on History Recall
Multitasking Behavior
Recruiting
Cognitive Control & the Functional Organization of the Frontal Cortex
Multitasking Behavior and Neural Representations Associated With Multitasking Ability, Healthy Volunteers
Enrolling by invitationObservational study
A New Dual Task Test Method for Football Players
Sports Physical Therapy, Multi-Tasking Behavior

All Multitasking Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: At-home Transcranial Alternating Current Stimulation During Multitasking
ClinicalTrials.gov ID: NCT04231825
Acronym / sponsor ID: 18-26268-1
Conditions: Multitasking Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 15 Oct 2019 (actual)
Primary completion: 15 Aug 2020 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 28 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Verum Stimulation	Experimental	Device: Transcranial alternating current stimulationThis group will receive 6-Hz tACS
Frequency Control	Active comparator	Device: Transcranial alternating current stimulationThis group will receive 1-Hz tACS

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

Neurological or psychiatric disorders
Family history of epilepsy
History of seizures
Prior head trauma
Pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial alternating current stimulationTranscranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.	Device	Frequency Control, Verum Stimulation

Primary outcome

Multitasking Performance Cost (Neuroracer Performance Change From Baseline)
Time frame: Pre-tACS and post-tACS (1 week later)
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.
Single Task Performance Change
Time frame: Pre-tACS and post-tACS (1 week later)
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.
Multitask Performance Change
Time frame: Pre-tACS and post-tACS (1 week later)
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.

2 secondary outcomes

Continuous Performance Test RT Change (Test of Visual Attention / Sustained Attention)
Time frame: Pre-tACS and post-tACS (1 week later)
Continuous Performance Test RTV Change (Test of Visual Attention / Sustained Attention)
Time frame: Pre-tACS and post-tACS (1 week later)

Results and safety

Results posted to the registry on 28 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Verum Stimulation	23	20
Frequency Control	24	20

Primary outcome: Multitasking Performance Cost (Neuroracer Performance Change From Baseline)

Time frame: Pre-tACS and post-tACS (1 week later). Mean (Standard Deviation). Unit: percentage change of d'

Measure	Verum Stimulation n = 20	Frequency Control n = 20
Value	45.3 (0.31)	37.9 (0.27)

Verum Stimulation vs Frequency Control: p = 0.55, ANCOVA

Population analysed: Only data from participants who completed the full protocol were analyzed

Primary outcome: Single Task Performance Change

Time frame: Pre-tACS and post-tACS (1 week later). Mean (Standard Deviation). Unit: d'

Measure	Verum Stimulation n = 20	Frequency Control n = 20
Value	1.99 (0.94)	2.70 (1.07)

Verum Stimulation vs Frequency Control: p = 0.02, ANCOVA

Population analysed: Only data from participants who completed the full protocol were analyzed

Primary outcome: Multitask Performance Change

Time frame: Pre-tACS and post-tACS (1 week later). Mean (Standard Deviation). Unit: d'

Measure	Verum Stimulation n = 20	Frequency Control n = 20
Value	1.17 (0.76)	1.79 (0.89)

Verum Stimulation vs Frequency Control: p = 0.03, ANCOVA

Population analysed: Only data from participants who completed the full protocol were analyzed

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Verum Stimulation	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Frequency Control	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Multitasking Behavior

RecruitingObservational study
Clinical Performance and Multitasking in Anesthesia : a Simulation-based Study
Multitasking Behavior and Multitasking Ability, Clinical Performance
Recruiting
Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults
Stress Response, Mental Stress
Recruiting
MultiCPR: The Influence of Resuscitation on History Recall
Multitasking Behavior
Recruiting
Cognitive Control & the Functional Organization of the Frontal Cortex
Multitasking Behavior and Neural Representations Associated With Multitasking Ability, Healthy Volunteers
Enrolling by invitationObservational study
A New Dual Task Test Method for Football Players
Sports Physical Therapy, Multi-Tasking Behavior

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theodore Zanto, Ph.D. principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial alternating current stimulation in people with Multitasking Behavior, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multitasking Performance Cost (Neuroracer Performance Change From Baseline) (time frame: Pre-tACS and post-tACS (1 week later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.