Measuring rTMS-induced Neuroplasticity With EEG Steady-state Visual-evoked Potentials
Inducing and Measuring Visual-evoked Potential Plasticity in Humans With Repetitive Transcranial Magnetic Stimulation
1 other identifier
interventional
60
1 country
1
Brief Summary
The goals of this study are to 1) use EEG steady-state visual evoked potentials as a noninvasive measure of the neuroplasticity induced by repetitive transcranial magnetic stimulation (rTMS), 2) use visual contrast detection paradigms as a behavioral measure of rTMS effects, and 3) to investigate how visual spatial attention augments or suppresses the neuroplastic impact of rTMS. Participants will observe visual stimuli on a screen while allocating their attention to different parts of the visual field and making responses when they observe changes in the visual stimuli. rTMS is performed to visual cortex using MRI-retinotopy neuronavigation. Then the visual task paradigm is performed again.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
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
First Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 22, 2024
April 1, 2024
3.8 years
May 2, 2023
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
post-rTMS change in ssVEP Response Amplitude
Change in ssVEP contrast-response amplitude after rTMS
60 minutes
post-rTMS change in visual contrast perceptual sensitivity
change in visual psychometric threshold across contrasts after rTMS
60 minutes
Study Arms (6)
Visual Cortex, 1 Hz rTMS, Attended
EXPERIMENTALVisual Cortex, 1 Hz rTMS, Unattended
EXPERIMENTALVisual Cortex, 10 Hz rTMS, Attended
EXPERIMENTALVisual Cortex, 10 Hz rTMS, Unattended
EXPERIMENTALVisual Cortex, Sham, Attended
SHAM COMPARATORVisual Cortex, Sham, Unattended
SHAM COMPARATORInterventions
Repetitive TMS targeted by neuronavigation to left lower visual field of primary visual cortex. Randomized to 10 Hz or 1 Hz on different treatment days. Stimulation at 110% of phosphene threshold, or 110% resting motor threshold if phosphenes not detectable. 1 Hz: 1000 pulses total over 1000 seconds. 10 Hz: 1000 pulses over 10 10 second pulse trains, with 50 second intertrain intervals
Eligibility Criteria
You may qualify if:
- Men and women, ages 18 to 65
- Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- Left- or Right-handed
- No current or history of neurological disorders
- No seizure disorder or risk of seizures
You may not qualify if:
- Those with a contraindication for MRIs (e.g. implanted metal)
- Any unstable medical condition
- History of head trauma with loss of consciousness
- History of seizures
- Neurological or uncontrolled medical disease
- Active substance abuse
- Diagnosis of psychotic or bipolar disorder
- Currently taking medications that substantially reduce seizure threshold (e.g., bupropion, olanzapine, chlorpromazine, lithium)
- Currently pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (1)
Stanford University
Stanford, California, 94306, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant is blind to the rTMS target hemisphere, the rTMS stimulation parameters, and the objective of the study
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
May 2, 2023
First Posted
May 11, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data will be available on reasonable request following completion of data collection.
- Access Criteria
- see above
The results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices. All publications will be made publicly available consistent with NIH policies. Research data, which documents, supports and validates research findings, will be made available after the main findings from the final research data set have been accepted for publication.