Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06331052
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-19
Brief Title:
3-D Tractography FUS Ablation for Essential Tremor
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
3-D Tractography Focused Ultrasound Ablation for Essential Tremor
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to advance Vim-FUSA Ventral Intermediate Nucleus - Focused Ultrasound Ablation with the support of 3-D tractography a neuroimaging technique to visually represent nerve tracts within the brain The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting The investigators also hypothesize that intraoperative magnetic resonance i-MR monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes
Detailed Description:
Essential tremor ET is a common neurological disorder and a leading cause of functional and psychological disabilities that can be difficult to suppress with oral medications many of which have considerable side effects limiting adequate dosing As a result up to 20 of ET patients cannot achieve satisfactory control of their symptoms and must consider interventional options Focused ultrasound ablation FUSA of the ventral intermediate nucleus Vim is an FDA-approved and Medicare-reimbursed procedure for ET resistant to medications that can selectively ablate the brain area associated with tremor without the need for surgical incisions or anesthesia The success of Vim-FUSA depends on the ability to accurately ablate 70 of the Vim volume without lesioning neighboring structures a goal that is complicated by technical challenges in three critical phases of the procedure planning identifying the Vim location and extension delivery ablating the Vim volume with adequate accuracy and monitoring confirming Vim ablation with reliable intraoperative imaging The investigators propose to advance Vim-FUSA with the support of 3-D tractography a neuroimaging technique to visually represent nerve tracts within the brain The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting The investigators also hypothesize that intraoperative magnetic resonance i-MR monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes Aim 1 Estimate and characterize the improvement in Vim ablation achieved with 3-D tractography Vim-FUSA vs standard Vim-FUSA in an experimental controlled animal study Through an experimental animal study the investigators will characterize the Vim ablation delivered with 3-D tractography Vim-FUSA in one hemisphere experimental group vs standard Vim-FUSA in the opposite hemisphere control group Aim 2 Test safety feasibility and preliminary efficacy and estimate effect size of 3-D tractography Vim-FUSA in a phase-II two-groups pre-post interventional human study In a human study the investigators will test the safety and feasibility of ablating 70 of the Vim volume while checking for side effects with intraoperative clinical testing Tremor assessments will be videotaped at baseline and 12 weeks and compared in a blinded fashion with age-sex matched controls randomly selected from the video repository of the two FDA-regulated studies of standard Vim-FUSA at baseline and 12 weeks Aim 3 Exploratory Assess the accuracy of i-MR in differentiating tissue ablation from immediate perilesional edema and its utility in predicting Vim-FUSA clinical outcomes In the experimental animal study the investigators will estimate and compare the accuracy of conventional and non-conventional i-MR in differentiating tissue necrosis from perilesional edema In the interventional human study the investigators will evaluate the utility of i-MR in predicting Vim-FUSA clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NS125386-01 | NIH | None | httpsreporternihgovquickSearch1R01NS125386-01 |