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NCT03192436 · ClinicalTrials.gov registry record · NA
Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
A NA study of Healthy, sponsored by Carnegie Mellon University.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT03192436: Recruiting NA study of Healthy, sponsored by Carnegie Mellon University.
NCT03192436 is a NA study of Healthy that is actively recruiting participants, run by Carnegie Mellon University. The registered enrollment target is 80 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192436, a NA study of Healthy, is actively recruiting participants, sponsored by Carnegie Mellon University.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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. Th
Conditions Studied
Interventions
- DEVICE Ultrasound
Study Locations (1)
Pennsylvania
- Department of Biomedical Engineering, Carnegie Mellon University - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2030-06-30 |
| Phase | NA |
What NCT03192436 shows while recruiting
NCT03192436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Ultrasound is the first listed.
NCT03192436 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03192436 about?
NCT03192436 is a clinical study titled "Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound". 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 dise...
What is the current status of trial NCT03192436?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2018-09-01. Estimated completion is 2030-06-30.
What conditions does trial NCT03192436 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03192436?
The interventions under investigation include: Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT03192436?
This trial is sponsored by Carnegie Mellon University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03192436 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03192436's enrollment target sits among peer trials
80 274th of 1090 higher than 802 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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