Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression

NCT05371041 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: IRB202102161UH3NS119844OCR41251
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will implant and monitor 8 research subjects with a subcortical closed-loop system for detection and suppression of tics in subjects with medically refractory debilitating Tourette Syndrome. 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.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Study Arms (1)

Medtronic Percept Neurostimulator

EXPERIMENTAL

This is a deep brain stimulator that can also record brain signals and deliver stimulation through a control algorithm based on brain activity.

Device: Medtronic Percept Neurostimulator

Interventions

Medtronic Percept Neurostimulator DEVICE

This is a deep brain stimulator that can also record brain signals and deliver stimulation through a control algorithm based on brain activity.

Medtronic Percept Neurostimulator

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of TS must be made by both a fellowship-trained movement disorders neurologist and a psychiatrist and must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a diagnosis of TS.
• There are no gender criteria for this study.
• The subject's TS symptoms must be medication refractory. To meet the medication refractory criteria, subjects must have been treated by a psychiatrist or neurologist experienced in TS with therapeutic doses (doses adapted from Scahill's recommendations of at least three dopamine blocking drugs) \[either 1-4 mg/day of haloperidol, 2-8 mg/day of pimozide, risperidone (1-3 mg/day), or aripiprazole (2.5-5 mg/day)\]. There must be at a minimum7 single trial with an alpha-2 adrenergic agonist (0.1-0.3 mg/day).
• Clinically relevant depression if present must be pharmacologically treated and deemed stable (by the study psychiatrist).
• Must have been stabilized for one month on TS medication without a dose change prior to surgical intervention. If medication trials resulted in discontinuation of TS medications, the subject must be stabilized for three months off TS medicines.
• Must be willing to keep TS related medications stable and unchanged throughout the trial.
• Must have been offered habit reversal therapy/cognitive behavioral intervention therapy (HRT) if a subject did not have it prior to enrollment. Subjects are not required to participate in HRT but it will be highly encouraged, and must be completed prior to the start of the protocol. Those who improve significantly with HRT will be excluded from receiving surgery.
• If the tic is focal or addressable by botulinum toxin treatment, the study neurologist will offer to administer a trial of botulinum toxin prior to consideration of surgical therapy. If the subject chooses not to have the treatment, they cannot participate in the study. If the subject responds satisfactorily to botulinum toxin, and their quality of life significantly improves, they will be excluded from the study.
• Must be 18 years of age or older.8

You may not qualify if:

• Any previous neurosurgical intervention such as DBS or ablative brain lesions. Participants with previous DBS system that have been explanted will still be excluded from the study.
• Any metal in the body that would preclude the patient from receiving an MRI scan.
• Untreated or unstable anxiety, depression, bipolar disorder or other Axis I psychiatric disorder.
• Presence of psychotic features.
• Significant psychosocial factors that may impart an increased risk.
• The presence of only simple motor tics, a movement disorder other than TS, or medication related movement disorders from TS medications.
• The presence of drug-induced tics (potentially associated with the use of stimulant medications, anticonvulsant drugs, etc.).
• Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, chronic neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians.
• Abnormal brain magnetic resonance imaging (MRI) scan including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions that would potentially confound the outcome or safety of the surgery as judged by the study neurosurgeon. Also excluded if severe atrophy is present on the brain scan.
• Dementia or cognitive dysfunction that will place the subject at risk for worsening cognition, and/or may impact the ability to cooperate with tasks involved in the study.
• Any attempt or intent of suicide in the last six months.
• Significant substance abuse or dependence (e.g., stimulants, alcohol, opiates, benzodiazepines) within the past six months.
• A positive urine drug screen for illicit substances (a urine drug screen is required), not to include marijuana/cannabinoid use.
• Patients who do not have access to a site that can program the device if they cannot come to The University of Florida for clinical re-programming follow-up appointments after completion of the study.
• Multiple failed medication treatments of inadequate dose or duration.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Norman Fixel Institute for Neurological Diseases - University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael Okun, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Christopher Butson, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Aysegul Gunduz, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 12, 2022
• Study Start: June 20, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)