Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

NCT03192436 | Recruiting

• 1 other identifier: STUDY2017_00000426
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging

  The primary study outcome is a closed-loop control algorithm to control the parameters in administrating the tFUS. The outcome data of the study will include the MRI data, EEG data, tFUS location and timing data, perceptual (subject reported) effects of tFUS and/or pins, and any reported adverse events. Analysis of the EEG data will be conducted using EEG analysis software, and the customized software to be developed at the PI's lab. The EEG data will also be correlated with tFUS application. The output of our data analysis process will be in the form of quantitative spatial estimation of tFUS activation in the brain using EEG source reconstruction.

  up to 2 years

Study Arms (2)

Real Ultrasound

ACTIVE COMPARATOR

The subjects will receive real ultrasound intervention.

Device: Ultrasound

Sham Ultrasound

SHAM COMPARATOR

The subjects will receive sham ultrasound intervention.

Device: Ultrasound

Interventions

Ultrasound DEVICE

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

Real Ultrasound; Sham Ultrasound

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy volunteers.
• Age 18-64.
• Willing and able to provide written consent.
• Able to communicate in the English language.

You may not qualify if:

• Subjects having any of the following conditions will be excluded from this study:
• Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder
• History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
• Personal or family history of seizure
• Any history of stroke/transient ischemic attack (TIA)
• Taking any medications that are known to decrease the threshold for seizure
• Pregnancy
• Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully considered by the PI
• Failure to follow laboratory or study procedures

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (1)

Department of Biomedical Engineering, Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bin He, Ph.D.

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Kosnoff

CONTACT

310-343-8702; jkosnoff@andrew.cmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 20, 2017
• Study Start: September 1, 2018
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)