NCT03560622

Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy

Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy for Tremor Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vibhor Krishna · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	multi-modality neuroimaging	multi-modality neuroimaging consists of structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI).

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-06-18
• Last updated: 2021-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study