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

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05853939
Collaborator
National Eye Institute (NEI) (NIH)
60
Enrollment
1
Location
6
Arms
47
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: repetitive transcranial magnetic stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Cross-over: 1 Hz vs 10 Hz vs sham rTMS; stimulation to attended or unattended hemisphereCross-over: 1 Hz vs 10 Hz vs sham rTMS; stimulation to attended or unattended hemisphere
Masking:
Single (Participant)
Masking Description:
Participant is blind to the rTMS target hemisphere, the rTMS stimulation parameters, and the objective of the study
Primary Purpose:
Basic Science
Official Title:
Inducing and Measuring Visual-evoked Potential Plasticity in Humans With Repetitive Transcranial Magnetic Stimulation
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Visual Cortex, 1 Hz rTMS, Attended

Device: 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
Experimental: Visual Cortex, 1 Hz rTMS, Unattended

Device: 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
Experimental: Visual Cortex, 10 Hz rTMS, Attended

Device: 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
Experimental: Visual Cortex, 10 Hz rTMS, Unattended

Device: 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
Sham Comparator: Visual Cortex, Sham, Attended

Device: 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
Sham Comparator: Visual Cortex, Sham, Unattended

Device: 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

Outcome Measures

Primary Outcome Measures

  1. post-rTMS change in ssVEP Response Amplitude [60 minutes]

    Change in ssVEP contrast-response amplitude after rTMS

  2. post-rTMS change in visual contrast perceptual sensitivity [60 minutes]

    change in visual psychometric threshold across contrasts after rTMS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94306

Sponsors and Collaborators

  • Stanford University
  • National Eye Institute (NEI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ryan Ash, Instructor, Stanford University
ClinicalTrials.gov Identifier:
NCT05853939
Other Study ID Numbers:
  • 62922
First Posted:
May 11, 2023
Last Update Posted:
May 11, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Ryan Ash, Instructor, Stanford University
visual-evoked potentials
TMS
neuroplasticity

Study Results

No Results Posted as of May 11, 2023