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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94306
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Visual Cortex, 1 Hz rTMS, Attended
|
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
|
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
|
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
|
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
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-rTMS change in ssVEP Response Amplitude
Time Frame: 60 minutes
|
Change in ssVEP contrast-response amplitude after rTMS
|
60 minutes
|
|
post-rTMS change in visual contrast perceptual sensitivity
Time Frame: 60 minutes
|
change in visual psychometric threshold across contrasts after rTMS
|
60 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Ryan Ash, MD, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 25-44827
- 5K08EY035037-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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