Occipital Transcranial Magnetic StimulationNCT02927470
TMS of Visual Working Memory
A study testing OffLine TMS Condition and Online TMS condition in people with Occipital Transcranial Magnetic Stimulation, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occipital Transcranial Magnetic Stimulation
- What is being tested?
- OffLine TMS Condition and Online TMS condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 25 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neurologically healthy individuals will be recruited.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Being tested
- Sham TMS condition, OffLine TMS Condition, Online TMS condition
- Keywords
- Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TMS conditionDevice
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 ConditionDevice
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 conditionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Working memory task | Experimental | 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. Receives: Device: Sham TMS condition; Device: OffLine TMS Condition; Device: Online TMS condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Accuracy (number of correct button presses) on the 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.
Measured: 1 Hour
Length of reaction time used in answering questions
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.
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Why it stopped: Investigators are no longer at NYU Langone Health
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occipital Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kartik Sreenivasan, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927470
- Sponsor's protocol ID
- 15-00666
- Status last verified
- Aug 2020
- First submitted
- 4 Oct 2016
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation of Visual Working Memory
- ClinicalTrials.gov ID
- NCT02927470
- Acronym / sponsor ID
- 15-00666
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators are no longer at NYU Langone Health
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Working memory task | Experimental | Device: Sham TMS condition, Device: OffLine TMS Condition, Device: Online TMS conditionSimple 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neurologically healthy individuals will be recruited.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham TMS conditionA 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. | Device | Working memory task |
| OffLine TMS ConditionA 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. | Device | Working memory task |
| Online TMS conditionA 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. | Device | Working memory task |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Sreenivasan principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OffLine TMS Condition and Online TMS condition in people with Occipital Transcranial Magnetic Stimulation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Accuracy (number of correct button presses) on the working memory task (time frame: 1 Hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.