3-D Tractography FUS Ablation for Essential Tremor

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2024

Primary Completion Date

February 28, 2028

Study Completion Date

February 28, 2028

Conditions
Essential Tremor
Interventions
DEVICE

MR-guided Focused Ultrasound Ablation

3-D tractography Vim-FUSA -D tractography Vim-FUSA will be carried out as follows: (a) head shaving and placement of the stereotactic frame (Integra radionics frame, Integra Lifesciences, NJ, USA) secured to the skull with transcutaneous screws; (b) positioning on the procedure table and placement of the ultrasound transducer; (c) acquisition of conventional magnetic resonance (MR) imaging and co-registration with the CT head and 3-D tractography imaging acquired pre-surgically; (d) exploration of the target area with subtherapeutic sonications; (e) intraoperative monitoring with clinical testing of tremor and side effects with a standardized protocol. (f) Therapeutic sonications in the target area to deliver definitive ablation followed by clinical testing of tremor and side effects with a standardized protocol as described in section (e).

Trial Locations (1)

27999

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

Texas Tech University Health Sciences Center, El Paso

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

University of North Carolina, Chapel Hill

OTHER