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Slow enrollment due to Covid-19.
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This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-response TMS - Intensity = 20%RMT | Experimental | Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
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| Dose-response TMS - Intensity = 40%RMT | Experimental | Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
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| Dose-response TMS - Intensity = 80%RMT | Experimental | Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
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| Dose-response TMS - Intensity = 120%RMT | Experimental | Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive TMS | Device | 1-10 Hertz rTMS will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motion Perception Accuracy | Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses) | during each TMS session, up to 3 hours |
| Reaction Time | Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms) | during each TMS session, up to 3 hours |
| Activation of Cortical Networks During a Visual Motion Task. | Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal | during each TMS session, up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).
Current serious medical illness (self report).
History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); [TMS Adult Safety Screening (TASS) form].
Subjects are unable or unwilling to give informed consent.
Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
Subjects with a clinically defined neurological disorder including, but not limited to:
i. Multiple sclerosis.
Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
Subjects with cochlear implants
Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
Women who are pregnant or breast-feeding (urine test).
Blindness.
Inability to read or understand English.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Study used a within-subjects design; all 27 participants received all 4 conditions ("arms") of TMS stimulation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS (Repetitive Transcranial Magnetic Stimulation) | Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Motion Perception Accuracy | Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses) | Within-subjects manipulation (same subjects for each condition). | Posted | Mean | Standard Error | Percentage of correct responses | during each TMS session, up to 3 hours |
|
Up to 3 months
Study used a within-subjects design; all 27 participants received all 4 conditions ("arms") of TMS stimulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-response TMS - Intensity = 20%RMT | Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon W Davis | Dept of Neurology, Duke University School of Medicine | 9195991927 | simon.davis@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2018 | Dec 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2022 | Oct 26, 2022 | ICF_001.pdf |
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The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).
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Participant is not informed about TMS intensity.
| years |
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| Sex: Female, Male | Within-subjects design, each subject received four TMS conditions ("arms"). | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Within-subjects design, all conditions ("arms") were repeated in each of the 27 participants. | Count of Participants | Participants |
|
| fMRI Activity | Measure reflects TMS-evoked activity associated with each TMS Intensity condition ("arm"), i.e., 20%, 40%, 80%, and 120% of an individualized resting motor threshold. | Mean | Standard Deviation | BOLD response |
|
Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
Repetitive TMS: 1-10 Hertz rTMS will be administered
| OG002 | Dose-response TMS - Intensity = 80%RMT | Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered |
| OG003 | Dose-response TMS - Intensity = 120%RMT | Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered |
|
|
| Primary | Reaction Time | Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms) | Within-subjects manipulation (same subjects for each condition). | Posted | Mean | Standard Error | milliseconds | during each TMS session, up to 3 hours |
|
|
|
| Primary | Activation of Cortical Networks During a Visual Motion Task. | Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal | Within-subjects manipulation (same subjects for each condition). | Posted | Mean | Standard Deviation | BOLD activity | during each TMS session, up to 3 hours |
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| 27 |
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| 27 |
| 0 |
| 27 |
| EG001 | Dose-response TMS - Intensity = 40%RMT | Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Dose-response TMS - Intensity = 80%RMT | Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | Dose-response TMS - Intensity = 120%RMT | Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. Repetitive TMS: 1-10 Hertz rTMS will be administered | 0 | 27 | 0 | 27 | 0 | 27 |
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