- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927470
TMS of Visual Working Memory
August 25, 2020 updated by: NYU Langone Health
Transcranial Magnetic Stimulation of Visual Working Memory
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance Accuracy (number of correct button presses) on the working memory task
Time Frame: 1 Hour
|
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.
|
1 Hour
|
Length of reaction time used in answering questions
Time Frame: 1 Hour
|
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.
|
1 Hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kartik Sreenivasan, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
April 25, 2018
Study Completion (Actual)
April 25, 2018
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
October 5, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 25, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-00666
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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