Recruiting

Transcranial Focused Ultrasound

Sponsor:

Carnegie Mellon University

Code:

NCT03192436

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Ultrasound

Study Details

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

Study ID

NCT03192436

Start date

Sep 1, 2018

Status verified date

Nov, 2025

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Real Ultrasound

The subjects will receive real ultrasound intervention.

sham comparator: Sham Ultrasound

The subjects will receive sham ultrasound intervention.

Interventions

Ultrasound

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joshua Kosnoff

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

Locations

Department of Biomedical Engineering, Carnegie Mellon University

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Joshua Kosnoff

jkosnoff@andrew.cmu.edu

Principal Investigator:

Bin He, PhD

More Information

Sponsor

Carnegie Mellon University

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carnegie Mellon University on 2025-11-14.