Optimizing Brain Excitability in Depression
Part of paid clinical trials in Iowa City, California.
- Sponsor
- Stanford University
- Study ID
- NCT07242105
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Active Single-Pulse TMS — DEVICESingle-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.
- Sham Single-Pulse TMS — DEVICESham single-pulse TMS is delivered using a flipped coil and concurrent scalp electrical stimulation to mimic auditory and somatosensory sensations without producing cortical stimulation.
- TARGET-optimized TMS — DEVICESingle-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.
- Non-optimized (Open-Loop) TMS — DEVICESingle-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.
- EEG Recording — OTHERParticipants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.
- Intracranial EEG (iEEG) Recording — OTHERNeurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.
Study Details
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).
Key Dates
- Start date
- Oct 23, 2025
- Status verified
- Feb 2026
- Primary completion
- Aug 30, 2029
- Completion
- Nov 30, 2029
Study Design
- Enrollment
- 145 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Active TMS, Sham TMS with iEEGNeurosurgical 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.
- Experimental: Sham TMS, Active TMS with iEEGNeurosurgical 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.
- Experimental: Optimized TMS, Non-optimized TMS with EEGParticipants 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.
- Experimental: Non-optimized TMS, Optimized TMS with EEGParticipants 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.
Primary Outcome Measure
Changes in Anterior EL-TEP Amplitude after single-pulse TMS (spTMS) [ Time Frame: Baseline, end of spTMS (6 hours) ]
Central Contacts
- Jade T Truong, BS408-840-3313
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa | Iowa City | California | 52246 | Aaron D Boes, MD, PhD (SUB_INVESTIGATOR) |
| Stanford University | Stanford | California | 94305 | Corey J Keller, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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