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The goal is to replicate in-lab results from transcranial alternating current stimulation (tACS) with at-home tACS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum Stimulation | Experimental | This group will receive 6-Hz tACS |
|
| Frequency Control | Active Comparator | This group will receive 1-Hz tACS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial alternating current stimulation | Device | Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Zanto, Ph.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandler Neurosciences Center | San Francisco | California | 94158 | United States |
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.
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.
Contact PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum Stimulation | This group will receive 6-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
| FG001 | Frequency Control | This group will receive 1-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only data from participants who completed the full protocol were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum Stimulation | This group will receive 6-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
| BG001 | Frequency Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only data from participants who completed the full protocol were analyzed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only data from participants who completed the full protocol were analyzed | Posted | Mean | Standard Deviation | percentage change of d' | Pre-tACS and post-tACS (1 week later) |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum Stimulation | This group will receive 6-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other (Not Including Serious) Adverse Event | Product Issues | Non-systematic Assessment | Device malfunction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Zanto | University of California San Francisco | 415-502-7322 | theodore.zanto@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2021 | Aug 11, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2019 | Aug 11, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073456 | Multitasking Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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) |
This group will receive 1-Hz tACS
Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Only data from participants who completed the full protocol were analyzed | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Only data from participants who completed the full protocol were analyzed | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only data from participants who completed the full protocol were analyzed | Count of Participants | Participants |
|
| Region of Enrollment | Only data from participants who completed the full protocol were analyzed | Count of Participants | Participants |
|
| Single Task Performance | 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). Performance was collected during the single task condition. | Only data from participants who completed the full protocol were analyzed | Mean | Standard Deviation | d' |
|
| Multitask performance | 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). Performance was collected during the multitasking condition. | Only data from participants who completed the full protocol were analyzed | Mean | Standard Deviation | d' |
|
| Multitasking Cost Performance | 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). Ratio of d' during single task target discrimination task to multitask target discrimination, expressed as percentage. | Only data from participants who completed the full protocol were analyzed. | Mean | Standard Deviation | Percent change |
|
| Continuous Performance Task RT | Response times (in ms) during the continuous performance (sustained attention) task. | Only data from participants who completed the full protocol were analyzed | Mean | Standard Deviation | milliseconds |
|
| Continuous Performance Task RTV | Response time variability (standard deviation of response times in ms) during the continuous performance (sustained attention) task | Only data from participants who completed the full protocol were analyzed | Mean | Standard Deviation | milliseconds |
|
| OG001 | Frequency Control | This group will receive 1-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. |
|
|
|
| Secondary | 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 | Only data from participants who completed the full protocol were analyzed | Posted | Mean | Standard Deviation | milliseconds | Pre-tACS and post-tACS (1 week later) |
|
|
|
|
| Secondary | 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 | Only data from participants who completed the full protocol were analyzed | Posted | Mean | Standard Deviation | milliseconds | Pre-tACS and post-tACS (1 week later) |
|
|
|
|
| Primary | 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. | Only data from participants who completed the full protocol were analyzed | Posted | Mean | Standard Deviation | d' | Pre-tACS and post-tACS (1 week later) |
|
|
|
|
| Primary | 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. | Only data from participants who completed the full protocol were analyzed | Posted | Mean | Standard Deviation | d' | Pre-tACS and post-tACS (1 week later) |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Frequency Control | This group will receive 1-Hz tACS Transcranial alternating current stimulation: Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4. | 0 | 24 | 0 | 24 | 2 | 24 |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|