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Altering Multitasking Behavior Using Low Current Brain Stimulation

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ClinicalTrials.gov Identifier: NCT03873636
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts University

Brief Summary:
This study is designed to investigate multitasking deficits, with a particular interest in reducing costs related to dual-tasking (dividing attention between tasks) and task-switching (switching between tasks) using noninvasive brain stimulation.

Condition or disease Intervention/treatment Phase
Cognitive Change Other: Stimulation via Soterix Medical noninvasive brain stimulation system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Altering Multitasking Behavior Using Low Current Brain Stimulation
Actual Study Start Date : December 27, 2016
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : September 18, 2019

Arm Intervention/treatment
Experimental: Active Stimulation
Active stimulation of targeted brain regions involved in task-switching and dual-tasking.
Other: Stimulation via Soterix Medical noninvasive brain stimulation system
Active (at or below 2mA) stimulation targeting brain regions engaged in task-switching and dual-tasking for 30-40 minutes. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.

Sham Comparator: Sham Stimulation
Sham stimulation of targeted brain regions involved in task-switching and dual-tasking.
Other: Stimulation via Soterix Medical noninvasive brain stimulation system
Active (at or below 2mA) stimulation targeting brain regions engaged in task-switching and dual-tasking for 30-40 minutes. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.




Primary Outcome Measures :
  1. Response accuracy [ Time Frame: 4 hours ]
    Measuring accuracy (correct vs. incorrect answers) of responses to stimuli while dividing attention and switching between tasks

  2. Response latency [ Time Frame: 4 hours ]
    Measuring the amount of time (seconds) from when stimulus is presented to when participant answers prompt



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be able to participate in non invasive brain stimulation research

Exclusion Criteria:

  • Any history of complications with non invasive brain stimulation research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873636


Contacts
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Contact: Kate Powell 6176271059 centerforabcs@tufts.edu
Contact: Nathan Ward, PhD Nathan.Ward@tufts.edu

Locations
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United States, Massachusetts
Tufts University Recruiting
Medford, Massachusetts, United States, 02155
Contact: Nathan Ward       nathan.ward@tufts.edu   
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Nathan Ward, PhD Tufts University

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03873636     History of Changes
Other Study ID Numbers: 1611020
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No