NCT04231825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 28, 2021

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

October 8, 2019

Results QC Date

August 11, 2021

Last Update Submit

March 10, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Continuous Performance Test RT Change (Test of Visual Attention / Sustained Attention)

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

  • Continuous Performance Test RTV Change (Test of Visual Attention / Sustained Attention)

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

Study Arms (2)

Verum Stimulation

EXPERIMENTAL

This group will receive 6-Hz tACS

Device: Transcranial alternating current stimulation

Frequency Control

ACTIVE COMPARATOR

This group will receive 1-Hz tACS

Device: Transcranial alternating current stimulation

Interventions

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

Frequency ControlVerum Stimulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandler Neurosciences Center

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Multitasking Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Dr. Theodore Zanto
Organization
University of California San Francisco

Study Officials

  • Theodore Zanto, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

January 18, 2020

Study Start

October 15, 2019

Primary Completion

August 15, 2020

Study Completion

September 15, 2020

Last Updated

March 21, 2022

Results First Posted

October 28, 2021

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
Access Criteria
Contact PI.

Locations