Brain Stimulation for the Treatment of Tourette Syndrome

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Brief Title

Brain Stimulation for the Treatment of Tourette Syndrome

Official Title

Scheduled and Responsive Brain Stimulation for the Treatment of Tourette Syndrome

Brief Summary

      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).
    

Detailed Description

      DBS is a surgical procedure that seeks to change the brain's electrical signalling by means
      of applied electrical current. To this end, a wire with tiny stimulating electrodes is
      implanted into one or both sides of the brain. An electrode is a small piece of metal used to
      take an electric current to or from a power source. These electrodes are connected under the
      skin on the scalp to a small electrical unit called an INS (implantable neurostimulator),
      which is similar to a heart pacemaker. The device sends out electrical impulses that appear
      to change the normal flow of electricity in the brain.

      The wires which house the electrodes will be implanted on both sides of the brain oriented
      towards the centromedian thalamus-parafascicular complex. This region of the brain has to
      date the greats number of documented cases revealing significant improvements in motor tics.

      This region of the brain will also provide a target where physiological changes related to
      motor tics are likely to be discovered.

      The device we propose for this study has several features that make it more suitable for use
      in the TS population than other devices. It is self-contained in the skull and brain, and
      contains no tunneled neck connector wire and no chest pacemaker deice. This will help to
      lessen infection, and will assist in limiting device-related fractures due to tics involving
      neck region. Also, the system can record electro-encephalograph data from the area of the
      electrodes, which will assist us in gathering information about what specific physiological
      changes are correlated with tics.
    


Study Type

Interventional


Primary Outcome

Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented

Secondary Outcome

 Correlation of Tics and Neural Physiology

Condition

Tourette Syndrome

Intervention

NeuroPace RNS® System Deep Brain Stimulator

Study Arms / Comparison Groups

 Delayed Activation - Deep Brain Stimulation (DBS)
Description:  Delayed Activation stimulation in which no electrical charge is delivered through the Neuropace RNS (responsive neurostimulation) system for the first 59 days. On Day 60, all subjects will be programmed to receive active stimulation.
There will be a one month post-operative period during which stimulation is not turned on.
One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days.

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

5

Start Date

September 2009

Completion Date

April 2017

Primary Completion Date

November 2011

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Okun, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01329198

Organization ID

414-2008- A


Responsible Party

Sponsor

Study Sponsor

University of Florida


Study Sponsor

Michael Okun, MD, Principal Investigator, University of Florida


Verification Date

June 2018