Healthy Clinical Trial - Electrophysiological Source Imaging Guided

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

In this protocol, the following hypothesis will be tested; the electroencephalography (EEG) and transcranial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT03192436
Study type	Interventional
Source	Carnegie Mellon University
Contact	Kai Yu, Ph.D.
Phone	(612) 323-9748
Email	yukai@cmu.edu
Status	Recruiting
Phase	N/A
Start date	September 1, 2018
Completion date	June 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06052553` - A Study of TopSpin360 Training Device	N/A
Completed	`NCT05511077` - Biomarkers of Oat Product Intake: The BiOAT Marker Study	N/A
Recruiting	`NCT04632485` - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed	`NCT05931237` - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults	N/A
Terminated	`NCT04556032` - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women	N/A
Completed	`NCT04527718` - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers	Phase 1
Completed	`NCT04107441` - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects	Phase 1
Completed	`NCT04998695` - Health Effects of Consuming Olive Pomace Oil	N/A
Completed	`NCT04065295` - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225	Phase 1
Completed	`NCT01442831` - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects	Phase 1
Terminated	`NCT05934942` - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood	Phase 1
Recruiting	`NCT05525845` - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI	N/A
Completed	`NCT05515328` - A Study in Healthy Men to Test How BI 685509 is Processed in the Body	Phase 1
Completed	`NCT05030857` - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects	Phase 1
Completed	`NCT04967157` - Cognitive Effects of Citicoline on Attention in Healthy Men and Women	N/A
Recruiting	`NCT04714294` - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers	Phase 1
Recruiting	`NCT04494269` - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls	Phase 1
Completed	`NCT04539756` - Writing Activities and Emotions	N/A
Recruiting	`NCT04098510` - Concentration of MitoQ in Human Skeletal Muscle	N/A
Completed	`NCT03308110` - Bioavailability and Food Effect Study of Two Formulations of PF-06650833	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms