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NCT06548113

Sensory Synchronized Imaging and Neuromodulation

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Oct 12, 2026 to Nov 30, 2026
  2. Start date: Jul 13, 2026 to Oct 12, 2026
    • Eligibility criteria expanded, about 7 words
    • Primary endpoints: details revised at 1 of 1 entry
  3. Primary and study completion pushed from Oct 1, 2029 to Dec 31, 2030
    • Start date: Jun 1, 2026 to Jul 13, 2026
    • Site contact updated
    v6
  4. Start date: Apr 1, 2025 to Jun 1, 2026
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: VA Palo Alto Health Care System to VA Office of Research and Development
    • Primary and study completion dates: Oct 2029 to Oct 1, 2029
    • Start date: Apr 2025 to Apr 1, 2025
    • Study site revised
    v3
  2. Lead sponsor: Stanford University to VA Palo Alto Health Care System
    • Start date: Oct 2024 to Apr 2025
    • Collaborators: 1 to 2
    v2
  1. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change
Timeframe: 45 minutes

Arms and interventions

Standard TMSActive comparator

A series of standard TMS protocols will be delivered to determine target engagement compared to seTMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.

Sensory-entrained TMS (seTMS)Active comparator

Sensory entrained TMS (seTMS) is a combination of music and TMS to align brain oscillations and enhance the effects of TMS. seTMS will be delivered to determine target engagement to noninvasive seTMS brain stimulation compared to standard TMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.

Devices: TMS

Sites

1 site in 1 country

  • VA Palo Alto Health Care System, Palo Alto, CAPalo Alto, California, United States