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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH139650 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TMS, Sham TMS with iEEG | Experimental | Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized. |
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| Sham TMS, Active TMS with iEEG | Experimental | Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized. |
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| Optimized TMS, Non-optimized TMS with EEG | Experimental | Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized. |
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| Non-optimized TMS, Optimized TMS with EEG | Experimental | Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Single-Pulse TMS | Device | Single-pulse transcranial magnetic stimulation is delivered to the left dorsolateral prefrontal cortex using a MagVenture X100 stimulator and B65 A/P coil across predefined locations, coil angles, and stimulation intensities. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS) | Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the anterior dlPFC. | Baseline, end of spTMS (6 hours) |
| Changes in Posterior EL-TEP Amplitude after spTMS | Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the posterior dlPFC. | Baseline, end of spTMS (6 hours) |
| Changes in intracranial TMS-Evoked Potential (iTEP) Amplitude after TMS-iEEG | Changes in the interaction between gyral/sulcal targets and coil angles (45 vs 90 degrees) on local dlPFC iTEP amplitude. | Baseline, end of spTMS (20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jade T Truong, BS | Contact | 408-840-3313 | kellerlab@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Corey J Keller, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Recruiting | Iowa City | California | 52246 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham Single-Pulse TMS | Device | Sham single-pulse TMS is delivered using a flipped coil and concurrent scalp electrical stimulation to mimic auditory and somatosensory sensations without producing cortical stimulation. |
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| TARGET-optimized TMS | Device | Single-pulse TMS parameters (location, angle, and intensity) are adjusted in real time using the TARGET closed-loop algorithm based on concurrent EEG measurements to deliver optimized stimulation. |
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| Non-optimized (Open-Loop) TMS | Device | Single-pulse TMS is delivered using a predefined open-loop set of stimulation parameter combinations across multiple dlPFC locations, coil angles, and intensities without real-time adjustment. |
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| EEG Recording | Other | Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses. |
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| Intracranial EEG (iEEG) Recording | Other | Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity. |
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| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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