NCT03192436 Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
| NCT ID | NCT03192436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carnegie Mellon University |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2018-09-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2018-09-01 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Bin He, Ph.D.
PRINCIPAL INVESTIGATOR
Carnegie Mellon University
Frequently Asked Questions
Who can join the NCT03192436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03192436 currently recruiting?
Yes, NCT03192436 is actively recruiting participants. Contact the research team at jkosnoff@andrew.cmu.edu for enrollment information.
Where is the NCT03192436 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT03192436 clinical trial?
NCT03192436 is sponsored by Carnegie Mellon University. The principal investigator is Bin He, Ph.D. at Carnegie Mellon University. The trial plans to enroll 80 participants.