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NCT03560622 · ClinicalTrials.gov registry record · NA
Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
A NA study of Essential Tremor, sponsored by Vibhor Krishna.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03560622: Active NA study of Essential Tremor, sponsored by Vibhor Krishna.
NCT03560622 is a NA study of Essential Tremor that is active but no longer recruiting, run by Vibhor Krishna. The registered enrollment target is 30 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03560622, a NA study of Essential Tremor, is active but no longer recruiting, sponsored by Vibhor Krishna.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Focused ultrasound for Essential Tremor is an FDA approved treatment performed by neurosurgeons at the Ohio State Center for Neuromodulation that utilizes ultrasound technology to create a lesion in the thalamus of Essential Tremor patients. In order to improve long term effectiveness and reduce potential for side effects, brain imaging may be used to examine the functional connectivity of certain brain networks during the procedure. In order to investigate functional connectivity changes with these long term goals in mind, in this study neuroimaging will be taken immediately before, immediately after, and 24 hours after the focused ultrasound procedure for 10 Essential Tremor patients. One series of neuroimaging will also be conducted for 20 healthy control subjects to serve as a comparison. This study will not introduce any risks above standard of care, and may lead to improved long term outcomes of patients undergoing the Focused Ultrasound procedure.
Primary Outcome
CCT will be calculated by analyzing and comparing functional connectivity in the tremor network in ET patients and healthy controls. The fMRI data will be acquired in two separate conditions: t-fMRI and rs-fMRI. Both t-fMRI and rs-MRI will be calculated based upon functional connectivity between the dentate nucleus, ventral intermediate nucleus, globus pallidus, motor and premotor cortex sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients f
Conditions Studied
Interventions
- DEVICE multi-modality neuroimaging
Study Locations (1)
Ohio
- The Ohio State Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the registry record for NCT03560622 still lists
NCT03560622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 1 intervention - of which multi-modality neuroimaging is the first listed.
NCT03560622 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03560622 about?
NCT03560622 is a clinical study titled "Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy". Focused ultrasound for Essential Tremor is an FDA approved treatment performed by neurosurgeons at the Ohio State Center for Neuromodulation that utilizes ultrasound technology to create a lesion in the thalamus of Essential Tremor patients. In order to improve long term effectiveness and reduce pot...
What is the current status of trial NCT03560622?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2018-09-01. Estimated completion is 2021-12-31.
What conditions does trial NCT03560622 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT03560622?
The interventions under investigation include: multi-modality neuroimaging (DEVICE).
Who is sponsoring clinical trial NCT03560622?
This trial is sponsored by Vibhor Krishna, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03560622 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03560622's enrollment target sits among peer trials
30 28th of 41 higher than 14 of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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