Study Stopped
In response to quality assurance and compliance concerns about some specific studies, NYSPI is undertaking an Institute-wide safety review of human subjects research protocols. HHS OHRP issued an FWA restriction on NYSPI research as of 2023/6/23.
Scaffolding of Brain Operations
BETATEST
1 other identifier
interventional
170
1 country
1
Brief Summary
Brain activity will be recorded while participants rest and/or perform perceptual discrimination tasks. These tasks include the presentation of sensory stimuli and require participants to detect and discriminate these stimuli, and to report about the objective properties of the stimuli as well as about their subjective perceptual experience using ratings of confidence, visibility, and/or alertness/sleepiness. All sensory stimuli used are neutral and consist of visual stimuli presented on a computer screen (either basic visual stimuli, e.g. an arrow, a grating or a dot, or neutral pictures of e.g. objects, buildings, landscapes), or auditory stimuli presented via headphones (either basic sounds, e.g. a beep or noise, or more complex sounds, e.g. a spoken word or rhythm). The experimental tasks may require participants to compare between sensory stimuli presented at different spatial locations or at different times, and/or to focus their attention on specific stimuli while suppressing distracting information; additionally, tasks may require participants to remember these stimuli for a delayed report. In these tasks, participants' performance will be quantified by motor responses (i.e., button press), reaction times and subjective ratings (confidence, visibility, alertness/sleepiness). Brain activity will be recorded by means of electroencephalography (EEG), a non-invasive technique consisting of electrodes placed along the scalp that record electrical field potentials generated by cortical neurons. EEG will be used to record brain activity prior to and in response to the sensory stimuli presented during the cognitive and perceptual tasks as well as during the participants' responses. Additionally, EEG may be used to record brain activity during a baseline resting state, while participants are not engaged in any particular tasks. In particular, the analysis of the EEG signal will focus on event-related brain activity (i.e., in response to the stimuli) such as event-related potentials (ERP), as well as ongoing and spontaneous and/or induced brain activity quantified as oscillations: wave-like signal fluctuations reflecting rhythmic variations of membrane potentials of cortical neurons. In addition, the investigators will use MRI to take an anatomical image of the brain to facilitate localizing the sources of the activity measured with EEG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2022
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 9, 2025
May 1, 2025
4.1 years
June 1, 2022
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
EEG spectral beta power
Brain activity will be recorded using 96-channel EEG (BrainVision actiCHamp system, Brain Products). Spectral analysis will be performed using the Matlab-based FieldTrip toolbox, a standard in the field. For all spectral analyses, subject-specific peak frequencies will be estimated to tailor the approach. Beta power will be assessed in a band centered at the individual peak frequency.
during procedure
Secondary Outcomes (2)
behavioral performance: accuracy
during procedure
behavioral performance: reaction time
during procedure
Study Arms (5)
Visual spatial discrimination task
OTHERexp 1.1
Visual spatial discrimination task with temporal manipulation
OTHERexp 1.2
Crossmodal discrimination task
OTHERexp 3.1
Visual rule-switching discrimination task [gratings]
OTHERexp 3.2
Visual rule-switching discrimination task [images]
OTHERexp 3.3
Interventions
Participants perform a discrimination task while their brain activity is recorded with EEG. Beta power will be estimated using spectral decomposition techniques, zooming in on subject specific bands in temporospatial windows of interest, and correlated with (1) WM content, (2) decision outcome, and (3) behavioral performance (i.e., accuracy and RT).
Eligibility Criteria
You may qualify if:
- English speaking
- Normal (or corrected-to-normal) vision, normal hearing
You may not qualify if:
- Epilepsy, past brain surgery, neurological or psychiatric disorders for which they are on medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Saskia Haegens, PhD
NYSPI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Neuroscience
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 9, 2022
Study Start
April 10, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 9, 2025
Record last verified: 2025-05