Measuring rTMS-induced Neuroplasticity With EEG Steady-state Visual-evoked Potentials

NCT ID: NCT05853939

Last Updated: 2024-04-22

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

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Visual Cortical Plasticity Repetitive Transcranial Magnetic Stimulation Visual Attention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-over: 1 Hz vs 10 Hz vs sham rTMS; stimulation to attended or unattended hemisphere
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participant is blind to the rTMS target hemisphere, the rTMS stimulation parameters, and the objective of the study

Study Groups

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Visual Cortex, 1 Hz rTMS, Attended

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Visual Cortex, 1 Hz rTMS, Unattended

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Visual Cortex, 10 Hz rTMS, Attended

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Visual Cortex, 10 Hz rTMS, Unattended

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Visual Cortex, Sham, Attended

Group Type SHAM_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Visual Cortex, Sham, Unattended

Group Type SHAM_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Interventions

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repetitive transcranial magnetic stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Ryan T. Ash MD, PhD

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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62922

Identifier Type: -

Identifier Source: org_study_id

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