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| Name | Class |
|---|---|
| Emory University | OTHER |
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Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults.
Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory.
The investigators will recruit a total of 16 neurotypical adults for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized brain state-dependent single-pulse TMS | Device | Single-pulse TMS will be applied to the right hemisphere during brain activity patterns associated with strong and weak corticospinal tract activation. Single-pulse TMS will also be applied to the right hemisphere during random brain activity patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor-evoked Potential (MEP) Amplitudes | Peak-to-peak MEP amplitudes elicited by single transcranial magnetic stimulation (TMS) pulses delivered during personalized strong and weak CST states will be measured from the left first dorsal interosseous muscle. At the individual participant level, all MEP amplitudes will be normalized to the mean MEP amplitude observed in that participant. Mean normalized MEP amplitudes will be compared across CST states. | single session |
| Measure | Description | Time Frame |
|---|---|---|
| State-targeting Accuracy | An offline version of the real-time EEG analysis algorithm will be used to determine the brain state (i.e., strong or weak CST states, or neither) immediately preceding delivery of each single TMS pulse. The proportion of trials during which the online and offline versions of the real-time EEG analysis algorithm produce the same brain state prediction will be calculated per participant and used as a state-targeting accuracy metric. State-targeting accuracy metrics will be compared to the theoretical chance level (0.5). |
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Inclusion Criteria:
Exclusion Criteria:
History of major neurological, orthopedic, psychiatric, or cardiovascular disease
Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39716573 | Result | Khatri UU, Pulliam K, Manesiya M, Cortez MV, Millan JDR, Hussain SJ. Personalized whole-brain activity patterns predict human corticospinal tract activation in real-time. Brain Stimul. 2025 Jan-Feb;18(1):64-76. doi: 10.1016/j.brs.2024.12.1193. Epub 2024 Dec 21. |
| Label | URL |
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| Raw data | View source |
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There were no specific pre-assignment procedures or events for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adults | Healthy adults first had single-pulse TMS delivered to the right motor cortex irrespective of ongoing brain activity (i.e., brain states) in order to generate a training dataset that included brain activity recordings and muscle responses to TMS delivery. Then, this training dataset was used to build a personalized mathematical model that discriminated between brain activity patterns reflecting strong and weak corticospinal tract (CST) activation (i.e., strong and weak CST states). After building this model, participants received single-pulse TMS to the right motor cortex during personalized brain states reflecting strong corticospinal tract (CST) activation (strong CST states), weak CST states, and random CST states. Stimulation was delivered at 120% of resting motor threshold and motor-evoked potentials (MEPs) were recorded from the left first dorsal interosseous muscle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Training Phase |
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| Testing Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adults | Healthy adults received single-pulse TMS the right motor cortex during personalized brain states reflecting strong corticospinal tract (CST) activation (strong CST states), weak CST states, and random CST states. Stimulation was delivered at 120% of resting motor threshold and motor-evoked potentials (MEPs) were recorded from the left first dorsal interosseous muscle. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
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| Age, Categorical | Count of Participants |
| 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 | Motor-evoked Potential (MEP) Amplitudes | Peak-to-peak MEP amplitudes elicited by single transcranial magnetic stimulation (TMS) pulses delivered during personalized strong and weak CST states will be measured from the left first dorsal interosseous muscle. At the individual participant level, all MEP amplitudes will be normalized to the mean MEP amplitude observed in that participant. Mean normalized MEP amplitudes will be compared across CST states. | Posted | Mean | Standard Error | arbitrary units (normalized microvolts) | single session |
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through study completion, an average of 1 day
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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 | Healthy Adults | Healthy adults received single-pulse TMS the right motor cortex during personalized brain states reflecting strong corticospinal tract (CST) activation (strong CST states), weak CST states, and random CST states. Stimulation was delivered at 120% of resting motor threshold and motor-evoked potentials (MEPs) were recorded from the left first dorsal interosseous muscle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Hussain, PhD | University of Texas at Austin | 5122322686 | sara.hussain@austin.utexas.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 | Aug 29, 2024 | Mar 25, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2024 | Feb 5, 2025 | ICF_002.pdf |
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Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation
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| single session |
| Analysis code | View source |
| Random CST States |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | Random CST States | Normalized MEPs elicited during random CST states were calculated. |
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| Secondary | State-targeting Accuracy | An offline version of the real-time EEG analysis algorithm will be used to determine the brain state (i.e., strong or weak CST states, or neither) immediately preceding delivery of each single TMS pulse. The proportion of trials during which the online and offline versions of the real-time EEG analysis algorithm produce the same brain state prediction will be calculated per participant and used as a state-targeting accuracy metric. State-targeting accuracy metrics will be compared to the theoretical chance level (0.5). | Posted | Mean | Standard Error | percentage of trials accurately targeted | single session |
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