Brain Stimulation for the Treatment of Tourette Syndrome

Completed · Not applicable

Conditions studied: Tourette Syndrome

In brief

The purpose of this trial is to determine whether a particular type of Deep Brain Stimulation (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe treatment for Tourettte syndrome (TS). The trial will also examine the brain activity associated with TS and tics and explore the possibility of responsive brain stimulation (RBS).

Key facts

Study ID

NCT01329198

Run by

University of Florida

People needed

5

Starts

2009-09-01

Expected to finish

2017-04-01

Last updated by the study team

2018-06-08

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of TS must be made by both a neurologist and a psychiatrist and must meet standardized criteria
• must have a minimum score on the primary tic rating scale
• symptoms must be causing significant impairment in functioning, making it impossible or almost impossible to do daily activities, including work or school and interactions with friends and family, causing severe distress and a poor quality of life
• symptoms have not responded well enough to medications prescribed by a neurologist or psychiatrist experienced in treating TS. Must have had trials of drugs from three different classes of drugs that have not worked.
• must have received stable and effective treatment of any other existing medical or psychological problems for the past 6 months.
• current TS related-medication(s) must be stable for at least a month without a dose change prior to surgery and must be willing to keep these medications stable and unchanged throughout the study or must be off of TS-related medications for at least three months prior to surgery
• If tics involve only one group of muscles or might be controllable by botulinum toxin treatment, must try botulinum treatment before considering surgery.
• must have a negative urine drug screen
• must give informed consent

You may not qualify if…

• have a simple motor tic or movement disorder other than TS, or medication-related movement disorders from TS medications
• have had any previous brain surgery including deep brain stimulation, ablative capsulotomy or cingulotomy
• have another psychiatric condition (including body dysmorphic disorder, a delusional disorder or a biological brain disorder), dementia or cognitive dysfunction that would place subject at risk for worsening cognition and/or may impact ability to comply with study procedures. Also included is any other psychiatric disorder that requires medications or treatments that would interfere with the functioning of the DBS device.
• have any significant substance abuse or dependence (e.g., stimulants, alcohol, opiates, benzodiazepines) within the past six months
• have a severe medical disease including cardiovascular disorder, lung disorder, kidney disease, chronic neurological disease, hematological disease, or frailty that impacts tolerability of the surgery as judged by the screening physicians
• pre-surgery MRI is considered abnormal. You may also be excluded if your brain is considered very small.
• have a history of serious suicidal behavior, are unable to control suicide attempts, or are currently at risk of suicide, in the judgement of the investigator
• have head-banging tics or tics that have the potential to damage the RNS System
• are currently pregnant or breast-feeding, plan to become pregnant during the study, or are not using effective contraception
• are currently enrolled in another investigational study
• have an implant such as a pacemaker or neurostimulator containing electrical circuitry or that generates electrical signals
• have any metal orthopedic pins or plates, metal orthodontics, or non-removable body jewelry
• require diathermy treatments during physical or occupational therapy
• have a problem that will require repeat Magnetic Resonance Imaging (MRI) scans

Where it is running

• University of Florida Movement Disorders Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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