ACTIVE_NOT_RECRUITING

Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Defining Targets for Tic Detection and Suppression in Tourette Syndrome Deep Brain Stimulation

Quick Facts

Study Start:2022-06-20

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05371041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Yale Global Tic Severity Scale (YGTSS; 100) must be \>35/50 and the motor tic sub score \>15. The TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption. OCD, Depression, and ADHD are not exclusionary provided tics are the major difficulty requiring surgical intervention. * 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	* • 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. * History of noncompliance with previous medical and psychosocial treatment efforts. * Severe head banging tics (any tics which have the potential to result in damage to the DBS as judged by the neurosurgeon). * Women of child-bearing potential who are pregnant or who wish to become pregnant during the study (a urine pregnancy screen required). * History of multiple surgical procedures with poor outcomes. * Unexplained gaps in medical history. * Pending lawsuits or other legal action.

Inclusion Criteria

Exclusion Criteria

* 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.
* Yale Global Tic Severity Scale (YGTSS; 100) must be \>35/50 and the motor tic sub score \>15. The TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption. OCD, Depression, and ADHD are not exclusionary provided tics are the major difficulty requiring surgical intervention.
* 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

* • 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.
* History of noncompliance with previous medical and psychosocial treatment efforts.
* Severe head banging tics (any tics which have the potential to result in damage to the DBS as judged by the neurosurgeon).
* Women of child-bearing potential who are pregnant or who wish to become pregnant during the study (a urine pregnancy screen required).
* History of multiple surgical procedures with poor outcomes.
* Unexplained gaps in medical history.
* Pending lawsuits or other legal action.

Contacts and Locations

Principal Investigator

Michael Okun, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Christopher Butson, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Aysegul Gunduz, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

Norman Fixel Institute for Neurological Diseases - University of Florida

Gainesville, Florida, 32608

United States

Collaborators and Investigators

Sponsor: University of Florida

Michael Okun, MD, PRINCIPAL_INVESTIGATOR, University of Florida
Christopher Butson, PhD, PRINCIPAL_INVESTIGATOR, University of Florida
Aysegul Gunduz, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-20

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-06-20

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Tourette Syndrome