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Clinical Trial Summary

The investigators will implant and monitor 8 research subjects with a subcortical closed-loop system for detection and suppression of tics. The project will use the FDA-approved "Medtronic Percept PC" device, which is an implantable neurostimulator capable of recording neural signals. The study will target the CM nucleus of the thalamus and the aGPi in each brain hemisphere from each subject and we will connect the two leads placed in each brain hemisphere to two Percept devices.


Clinical Trial Description

Tourette syndrome (TS) is a continuous lifelong disabling condition that is highly prevalent and socially embarrassing. DBS has emerged as a promising treatment option for addressing uncontrollable tics in medically resistant and severe cases of TS frequently involving self-injurious behavior. The investigators have undertaken a major informatics initiative by establishing the International TS DBS Registry and Database, a multi-country consortium that has captured long term outcomes of 277 TS DBS patients representing 50-75% of the worldwide population. From these outcomes, two deep brain targets have emerged as potentially effective: the centromedian nucleus region (CM) of the thalamus, and the anterior globus pallidus internus (aGPi). However, the current understanding of tic generation is limited by many factors including a lack of animal models for TS, normal brain structure as revealed by structural imaging, and the impracticality of studying involuntary motor tics with functional imaging. Next generation closed-loop DBS systems can record brain activity in patients with TS and identify the neurophysiological correlates of tics. Moreover, these devices can deliver stimulation in response to a patient's symptomatic state. Our overall goal is to develop neurophysiology driven and connectivity-guided closed-loop DBS systems for the improved treatment of TS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05371041
Study type Interventional
Source University of Florida
Contact Emily Rafferty, PhD
Phone 352-733-0082
Email mahoneye@ufl.edu
Status Recruiting
Phase N/A
Start date June 20, 2022
Completion date August 31, 2026

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