A Tourette Syndrome clinical trial begins in United States.

The research company University of Florida is conducting the clinical trial Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression.

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.

It is planned to include 8 participants.

Actual study start date is May 10, 2022. The researchers expect to complete the study by August 31, 2026.

One primary outcome measure is Yale Global Tic Severity Scale_(YGTSS) - Total Tic Score, The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics - scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from 0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05371041.

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