Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorCarnegie Mellon University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Apparently healthy volunteers.
Age 18-64.
Willing and able to provide written consent.
Able to communicate in the English language.
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Ultrasound
DeviceLow-intensity (Ispta \< 720 mW/cm2, Isppa \< 190 W/cm2) transcranial focused ultrasound
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Real UltrasoundActive comparator 1 intervention
Group B: Sham UltrasoundSham comparator 1 intervention
Trial outcomes
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.
Time frame
up to 2 yearsSponsors and contacts
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Carnegie Mellon University
Lead sponsor
University of Minnesota
Sponsor institution
Source ClinicalTrials.gov