Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression

Launched by UNIVERSITY OF FLORIDA · May 11, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for Tourette Syndrome (TS) using a device called a neurostimulator, which is implanted in the brain. The goal is to help detect and reduce tics, which are sudden, repetitive movements or sounds that can be distressing and disruptive for people with TS. The researchers will monitor eight participants who have severe tics that haven’t improved with medication. The study uses a system that can both record brain activity and provide stimulation to help control these tics.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of Tourette Syndrome confirmed by both a neurologist and a psychiatrist. They should have tried several medications without success and still experience significant distress from their tics. Participants will need to maintain their current medications throughout the trial and may be encouraged to try behavioral therapy beforehand. It's important to note that there are some conditions that would exclude someone from participating, such as having had prior brain surgery or certain mental health issues. Overall, this trial aims to offer hope for those struggling with severe tics and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion 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 subscore \>15. The TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption. Obsessive Compulsive Disorder (OCD), Depression, and Attention Deficit Hyperactivity Disorder (ADHD) are not exclusionary4-6 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 drugs5) 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.
• • Must be 18 years of age or older
• Exclusion Criteria:
• • Any previous neurosurgical intervention including DBS or ablative brain lesions, any metal in the head and any type of implanted stimulator.
• • 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.
• • 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.