Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Carnegie Mellon University
Study ID
NCT03192436
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound — DEVICE
    Low-intensity (Ispta \< 720 mW/cm2, Isppa \< 190 W/cm2) transcranial focused ultrasound

Study Details

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.

Key Dates

Start date
Sep 1, 2018
Status verified
Nov 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Real Ultrasound
    The subjects will receive real ultrasound intervention.
  • Sham Comparator: Sham Ultrasound
    The subjects will receive sham ultrasound intervention.

Primary Outcome Measure

Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging [ Time Frame: up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Biomedical Engineering, Carnegie Mellon UniversityPittsburghPennsylvania15213
Joshua Kosnoff
[email protected]
Bin He, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Department of Biomedical Engineering, Carnegie Mellon University· Pittsburgh, PA

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