Tourette Syndrome Deep Brain Stimulation

Purpose

The purpose of this study is to learn how deep brain stimulation affects motor and vocal tics associated with severe Tourette Syndrome that is not adequately controlled with medication. The study period is 36 months, or 3 years.

Procedures

  • You will be screened for surgical candidacy and if eligible, you will undergo implantation of two leads deep into your brain and 2 brain sensors (cortical strips) on the top of your brain.
  • This study involves 2 surgeries: one awake brain surgery and one outpatient battery placement under general anesthesia.
  • The brain sensors allow the research team to evaluate brain activity that may be related to your tics, and the leads provide stimulation to hopefully reduce frequency and severity of your tics.

Eligibility

  • 21 years and older
  • Diagnosis of Tourette Syndrome (TS) in accordance to the Diagnostic and Statistical Manual of Mental DIsorders (DSM-V) criteria
  • Yale Global Tic Severity Scale (YGTSS) must be ≥35/50 for at least 12 months; Motor Tic subscore must be ≥15
  • TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption
  • TS must be medication refractory. Criteria to determine if medication refractory is the exact criteria stated by Mink et. al TSA DBS
  • Guidelines published in 2006: Subjects must have been treated by a psychiatrist or neurologist experienced in TS with therapeutic doses of either 1-4 mg/day of haloperidol or 2-8 mg/day of pimozide, risperidone (1-3 mg/day), and aripiprazole (2.5-5 mg/day)
  • Must be at minimum a single trial with an alpha-2 adrenergic agonist (0.1-0.3 mg/day)
  • Clinically relevant depression must be pharmacologically treated and deemed stable
  • Must have been stabilized for 1 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 3 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 subject did not have it prior to enrollment. (Subjects not required to participate in HRT but it will be highly encouraged, and must be completed prior to start of this study's protocol. Those who improve significantly will be excluded from receiving DBS surgery)
  • If 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 patient responds satisfactorily and their quality of life significantly improves, they will be excluded)

For additional study details and eligibility criteria, please contact the study team: 

Age

18 to 65

Gender

Male
Female

Can be done from home

No

Keywords

Tourette Syndrome, Neurology

Principal Investigator

Michael S. Okun, MD

Department

Neurology

Contact Information

cami.swartz@neurology.ufl.edu

(352) 265-8408


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