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Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03192436
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Carnegie Mellon University

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.

Condition or disease Intervention/treatment Phase
Healthy Device: Ultrasound Not Applicable

Detailed Description:
In this protocol, the following hypothesis will be tested; the electroencephalography (EEG) and trancranial focused ultrasound (tFUS) will be used to quantify and optimize stimulation effects. We will test the hypothesis that tFUS can induce regional brain activity and use EEG to localize and image the brain electrical activity as induced by TFUS stimulation. Subjects will be recruited for MRI scan and then undergo motor and/or sensory tasks, and during these tasks, subjects will receive tFUS and concurrently be monitored by EEG. This tFUS-EEG study is aimed at exploring effects of tFUS and the use of EEG in providing electrophysiological responses to brain activation following tFUS stimulation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Real Ultrasound
The subjects will receive real ultrasound intervention.
Device: Ultrasound
Low-intensity (Ispta < 720 mW/cm2, Isppa < 190 W/cm2) transcranial focused ultrasound

Sham Comparator: Sham Ultrasound
The subjects will receive sham ultrasound intervention.
Device: Ultrasound
Low-intensity (Ispta < 720 mW/cm2, Isppa < 190 W/cm2) transcranial focused ultrasound

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03192436

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Contact: Kai Yu, Ph.D. (612) 323-9748
Contact: Emily Lopez

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United States, Pennsylvania
Biomedical Engineering Department Carnegie Mellon University Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kai Yu, PhD.    612-323-9748   
Contact: Emily Lopez, B.S.    518-322-1579   
Principal Investigator: Bin He, PhD         
Sponsors and Collaborators
Carnegie Mellon University
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Principal Investigator: Bin He, Ph.D. Carnegie Mellon University
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Responsible Party: Carnegie Mellon University Identifier: NCT03192436    
Other Study ID Numbers: STUDY00000449
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No