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Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2030
    • Site contact updated
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025v12
  4. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: May 31, 2022 to Jun 30, 2024
    • Site details revised
    v11
  5. Primary completion date: Aug 2021 to May 31, 2022
    • Study completion date: Mar 2022 to May 31, 2022
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study description revised
    • Study site revised
    v9
  2. Site contact updatedv8
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2018 to Sep 1, 2018
    v7
  4. Lead sponsor: University of Minnesota to Carnegie Mellon University
    • Study description expanded, about 107 words
    v6
  5. Start date: Jan 2018 to Sep 2018v5
  6. Start date: Oct 2017 to Jan 2018v4
  7. Start date: Sep 2017 to Oct 2017v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuromodulation is a fast growing field that offers a wide range of applications for both understanding and treating the brain. Future research for non-invasive neuromodulation will need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety of technologies and diseases. Closed loop stimulation is thus a promising research area that allows for responsive stimulation and real time symptom management. Our project is proposed to develop and test a novel noninvasive neuromodulation integrating transcranial focused ultrasound stimulation (tFUS) with electrophysiological source imaging (ESI-tFUS) to allow evidence-based neuromodulation for brain research and the management of brain conditions. Despite the recent developments and attention surrounding tFUS, relatively little is known about the mechanisms and optimal parameters of this stimulation technology. The addition of ESI neuroimaging, aimed at providing biomarkers to assess the effects of tFUS neuromodulation, could provide crucial necessary information regarding the neural response to the applied stimulation in real-time. In order for tFUS to be further developed and transformed into a robust neuromodulation technology, an integrated electrophysiological source-imaging-guided tFUS system to allow for individualized and responsive stimulation is needed. The purpose of this study is to develop and evaluate the proposed ESI-tFUS in human subjects using motor and somatosensory paradigms.
Trial Details
NCT Number NCT03192436
Lead Sponsor Carnegie Mellon University
Conditions
(from sponsor)		 Healthy
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov