TMS of Visual Working Memory

NCT ID: NCT02927470

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to understand how the brain allows individuals to keep information "in mind" over brief intervals. During the experiment, participants will be asked to maintain fixation while they attend to and remember different visual stimuli (e.g., the location of a dot on the screen, the color of a circle, the orientation of a line, the speed of a group of moving dots) on a computer monitor. Participants will make decisions about these visual stimuli and indicate their decisions by pressing buttons or making eye movements. Through the use of Transcranial Magnetic Stimulation (TMS) investigators hope to understand the contributions of different anatomical areas while subjects perform this task.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will use a within subject design in which each participant will perform a working memory task combined with Transcranial Magnetic Stimulation. TMS will be applied in three possible procedures, 1) Online TMS, 2) Offline TMS and 3) Sham TMS. All subjects will be given two trials within their one session, one of which will be sham TMS for all subjects and another of which will be randomly assigned to either Online or Offline TMS. Trials order will be randomly counterbalanced across subjects, who will be blind to the treatment of frontal vs. sham TMS (independent variable). Participants will be randomized into either the online or offline groups by computer generated lists to ensure equal numbers of participants in each condition. Half of the subjects will receive online TMS (online group) and half will receive offline TMS (offline group). Subjects will be randomly assigned to one of the two groups. The dependent variables will be performance accuracy and reaction time on the working memory task. By utilizing online and offline TMS, investigators will be able to explore whether frontal cortex is involved transiently in visual working memory or persistently throughout the task.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Occipital Transcranial Magnetic Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Working memory task

Simple visual stimuli (e.g., dots, colors, lines) will be presented on a computer monitor. The positions of the stimuli must be attended and remembered and decisions about the stimuli and/or their locations must be made. Memory will be probed with a button press or an eye movement towards the remembered locations.

Group Type EXPERIMENTAL

Sham TMS condition

Intervention Type DEVICE

A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of sham TBS, the subject will perform the working memory task for 45 minutes.

OffLine TMS Condition

Intervention Type DEVICE

A total of 200 trains will be delivered successively in 40 s, totaling 600 pulses. The pulses will be delivered at 80% of motor thresholds. A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of TBS, or sham TBS, the subject will perform the working memory task for 45 minutes.

Online TMS condition

Intervention Type DEVICE

A single train of pulses (3 pulses at 50Hz, duration 40ms) will be delivered once during a particular time epoch on each trial, followed by a minimum of 6 seconds of no stimulation. No more than 600 pulses will be applied in a single session. Similar to the offline TMS condition, a sham TMS coil will be used to measure baseline performance on the working memory task. In each session (frontal, sham) subjects will perform the working memory task for 45 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sham TMS condition

A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of sham TBS, the subject will perform the working memory task for 45 minutes.

Intervention Type DEVICE

OffLine TMS Condition

A total of 200 trains will be delivered successively in 40 s, totaling 600 pulses. The pulses will be delivered at 80% of motor thresholds. A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of TBS, or sham TBS, the subject will perform the working memory task for 45 minutes.

Intervention Type DEVICE

Online TMS condition

A single train of pulses (3 pulses at 50Hz, duration 40ms) will be delivered once during a particular time epoch on each trial, followed by a minimum of 6 seconds of no stimulation. No more than 600 pulses will be applied in a single session. Similar to the offline TMS condition, a sham TMS coil will be used to measure baseline performance on the working memory task. In each session (frontal, sham) subjects will perform the working memory task for 45 minutes.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neurologically healthy individuals will be recruited.

Exclusion Criteria

* Individuals with neurological issues (e.g., history of seizures, neurosurgery, brain trauma) will be excluded.
* Women of childbearing potential will be told that although there are no known risks of the procedure to the unborn fetus, they should not take part in the study if they are or might be pregnant.
* Minors and the elderly will be excluded.
* Individuals who are on medications that heighten the risk of TMS adverse events will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kartik Sreenivasan

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York University School of Medicine

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-00666

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Network Control TMS fMRI
NCT05736458 TERMINATED NA