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Brain Stimulation for the Treatment of Tourette Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01329198
First received: March 25, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this research study is to evaluate the effectiveness and safety of a possible new treatment for Tourette Syndrome (TS). It is a new type of Deep Brain Stimulation (DBS) called Scheduled Brain Stimulation (SBS). The study will also examine the physiology (brain activity) associated with TS and tics and explore the possibility of responsive brain stimulation (RBS).

DBS is a surgical procedure that involves putting a wire with tiny stimulating electrodes into each side of your 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 to a small electrical unit called an INS (implantable neurostimulator). The INS is similar to a heart pacemaker. In order for your brain to send messages to your body, it produces a form of electricity. The device sends out electrical impulses that appear to interrupt this flow of electricity.

The use of DBS in the treatment of TS is investigational, which means it has not been approved by the Food and Drug Administration (FDA). DBS is approved by the FDA for use in people with uncontrollable shaking (essential tremors) and Parkinson's disease.


Condition Intervention
Tourette Syndrome
 Device: NeuroPace RNS® System Deep Brain Stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scheduled and Responsive Brain Stimulation for the Treatment of Tourette Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Yale Global Tic Severity Scale (YGTSS) [ Time Frame: six months ] [ Designated as safety issue: No ]
    The YGTSS is a semistructured clinician-rated instrument that assesses the nature of motor and phonic tics over the previous week. The clinician initially notes the presence of motor and phonic tics based on child and parent(s) reports and behavioral observations. Following this, the clinician rates the severity of motor and phonic tics on five separate dimensions each: number, frequency, intensity, complexity, and interference. Five index scores are obtained: Total Motor Tic Score, Total Phonic Tic Score, Total Tic Score, Overall Impairment Rating, and Global Severity Score.


Estimated Enrollment: 6
Study Start Date: September 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham DBS
Sham NeuroPace DBS
 Device: NeuroPace RNS® System Deep Brain Stimulator
  • 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.
Other Name: NeuroPace DBS
Active Comparator: Active DBS
Active NeuroPace DBS
 Device: NeuroPace RNS® System Deep Brain Stimulator
  • 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.
Other Name: NeuroPace DBS

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329198

Locations
United States, Florida
University of Florida Movement Disorders Center
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael Okun, MD University of Florida
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01329198     History of Changes
Other Study ID Numbers: 00068500
Study First Received: March 25, 2011
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013