Tourette Syndrome Deep Brain Stimulation

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Brief Title

Tourette Syndrome Deep Brain Stimulation

Official Title

The Human Thalamocortical Network in Tourette Syndrome

Brief Summary

      The purpose of this study is to evaluate the effectiveness and safety of deep brain
      stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).

      This investigation will (1) test the hypothesis that centromedian (CM) continuous brain
      stimulation will be an effective, safe method for the treatment of tics in medication
      refractory TS, (2) will define the intra-operative and post-operative physiological changes,
      and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an
      alternative to chronic DBS in TS.
    

Detailed Description

      Normal clinical care for TS includes cognitive behavior therapy, medication, supportive
      psychotherapy, and/or a combination of the two. To meet entry criteria for this study, you
      must have already tried these methods and they did not help your symptoms. DBS is considered
      experimental for the treatment of TS and would not be done as normal clinical care.

      Participation in this study will require extensive pre-surgical screening to determine
      eligibility for DBS surgery, a DBS surgical procedure, and regular follow-ups. Subjects will
      be seen monthly post surgery for 6 months. After 6 months, data will be assessed and RBS may
      be offered as a stimulation setting. If so, the stimulator settings will be changed from
      chronic to responsive. If not, the subject will continue to receive chronic DBS stimulation.
      Subsequent visits will be scheduled every 6 months until a total of 24 months of study
      participation.

      At the end of the initial 24-month study period, subjects will have the choice of 1)
      continuing active stimulation at the current setting, 2) continuing stimulation but searching
      for a new setting, 3) discontinuing stimulation (turning the device off), 4) having the
      device removed. If the subject continues to receive active stimulation, they will be followed
      by the PI and seen at yearly intervals until the DBS system is commercially available, FDA
      approved for the treatment of TS, or unavailable for patient use.
    


Study Type

Interventional


Primary Outcome

Reduction in total tics on the Yale Global Tic Severity Scale (YGTSS) after 6 months as an effect of centromedian (CM) continuous DBS stimulation


Condition

Tourette Syndrome

Intervention

DBS System

Study Arms / Comparison Groups

 Deep Brain Stimulation (DBS)
Description:  Subjects' DBS surgical intervention requires implantation of a DBS system: two CM thalamic leads (one in each brain hemisphere), two ECOG strip leads (one in each brain hemisphere), and two neurostimulators implanted in the chest.
The ECOG strip lead is implanted into the brain to provide an interface through which stimulation can be delivered or activity of the brain can be monitored by the device, or observed by a clinician using a programmer.
Neurostimulator and leads system includes a programmer, which includes a wand and telemetry interface, and a patient remote control to check battery status and whether the device is on or off. The programmer is used to set up the device, including setup of stimulation and recording, as well as to retrieve data for subsequent review.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

May 2014

Completion Date

October 2021

Primary Completion Date

October 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Must be 21+ years of age

          -  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)

        Exclusion Criteria:

          -  Any previous neurological 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 can cause increased risk

          -  The presence of only simple motor tics, a movement disorder other than TS, or
             medication related movement disorders from TS medications

          -  Severe medical co-morbidity 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

          -  Abnormal brain magnetic resonance imaging (MRI) scan, including severe atrophy,
             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

          -  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 6 months

          -  Significant substance abuse or dependence within the last 6 months

          -  Multiple failed medication treatments of inadequate dose or duration

          -  History of noncompliance with previous medical and psychosocial treatment efforts

          -  Severe head banging tics

          -  Women of child-bearing potential who are pregnant or planning pregnancy (urine
             pregnancy test required)

          -  Positive urine drug screen for illicit substances (urine drug screen required)

          -  History of multiple surgical procedures with poor outcomes

          -  Unexplained gaps in medical history

          -  Pending lawsuits or other legal action
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Okun, MD, 352-733-2429, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02056873

Organization ID

IRB201300850 -A-N

Secondary IDs

KL2TR001429

Responsible Party

Sponsor

Study Sponsor

University of Florida

Collaborators

 Medtronic

Study Sponsor

Michael Okun, MD, Principal Investigator, University of Florida


Verification Date

July 2021