Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Essential Tremor
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Ten adults with refractory ET (ET cohort) and 20 healthy controls (control cohort) will undergo multi-modality neuroimaging (structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI)). In addition the ET cohort will also undergo imaging with the identical protocol immediately after and 24 hours after FUS-T.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
To calculate the connectivity correlates of tremor (CCT) 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. a. For t-fMRI, patients will perform simple repetitive...
To calculate the connectivity correlates of tremor (CCT) 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. a. For t-fMRI, patients will perform simple repetitive tasks (e.g. finger tapping, hand grasping) to identify activation clusters within tremor network. Functional connectivity between the clusters will be calculated by creating cross-correlation matrices. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. b. For rs-fMRI the hubs within tremor network will be identified with a state-of-the-art multimodality atlas. Cross-correlation matrices will be created to calculate measures of functional connectivity. A sensitivity analysis will then be performed to determine an optimal value of CCT to distinguish ET patients from controls. 2. To study changes in functional connectivity in the tremor network before, immediate postoperative and and 24-hours after FUS-T in ET patients. a. The CCT will be calculated and compared between baseline, immediate postoperative and 24-hours post-operative conditions to determine the effect of FUS-T. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and for rs-fMRI. b. The CCT in immediate postoperative and 24-hours post-operative condition among ET patients will be compared to healthy controls to determine whether FUS-T restored the abnormal connectivity in tremor network. For this sub-aim the connectivity data will be separately analyzed for t-fMRI and rs-fMRI.
Tracking Information
- NCT #
- NCT03560622
- Collaborators
- National Institutes of Health (NIH)
- Focused Ultrasound Foundation
- Investigators
- Principal Investigator: Vibhor Krishna, MD SM Ohio State University
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