RECRUITING

Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

Quick Facts

Study Start:2018-09-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03192436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Apparently healthy volunteers.
  2. * Age 18-64.
  3. * Willing and able to provide written consent.
  4. * Able to communicate in the English language.
  1. * Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder
  2. * 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
  3. * Personal or family history of seizure
  4. * Any history of stroke/transient ischemic attack (TIA)
  5. * Taking any medications that are known to decrease the threshold for seizure
  6. * Pregnancy
  7. * 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
  8. * Failure to follow laboratory or study procedures

Contacts and Locations

Study Contact

Kai Yu, Ph.D.
CONTACT
(612) 323-9748
yukai@cmu.edu

Principal Investigator

Bin He, Ph.D.
PRINCIPAL_INVESTIGATOR
Carnegie Mellon University

Study Locations (Sites)

Department of Biomedical Engineering, Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Carnegie Mellon University

  • Bin He, Ph.D., PRINCIPAL_INVESTIGATOR, Carnegie Mellon University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2018-09-01
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy