Brain Stimulation for the Treatment of Tourette Syndrome

NCT01329198 | Completed Results DMC FDA Device

• 1 other identifier: 414-2008- A
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Tourette Syndrome

Keywords

tourette; tourette's; TS; tourette syndrome; tourette's syndrome

Outcome Measures

Primary Outcomes (1)

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

  The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: * Total Motor Tic Score (0-25) * Total Phonic Tic Score (0-25 * Total Tic Score (0-50) * Overall Impairment Rating (0-50) * Global Severity Score (0-7) The YGTSS Total Score is obtained by adding the Total Tic Score to the Overall Impairment Rating. The efficacy of the intervention will be assessed by comparing each subject's 6-month YGTSS Total Score to the pre-operative value for the same patient. Efficacy is considered 50% or greater reduction in this score.

  Baseline to 6 Months

Secondary Outcomes (1)

• Correlation of Tics and Neural Physiology

  Baseline to 6 Months

Study Arms (2)

Delayed Activation - Deep Brain Stimulation (DBS)

ACTIVE COMPARATOR

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.

Device: NeuroPace RNS® System Deep Brain Stimulator

Immediate Activation - Deep Brain Stimulation (DBS)

ACTIVE COMPARATOR

Active stimulation through the Neuropace RNS (responsive neurostimulation) system at settings to maximally reduce tic frequency \& severity, while limiting potential stimulation-induced side-effects. * 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.

Device: NeuroPace RNS® System Deep Brain Stimulator

Interventions

NeuroPace RNS® System Deep Brain Stimulator DEVICE

Utilizes a signal that the device detects and will respond to with an electrical pre-defined pulse if the signal is encountered.

Also known as: NeuroPace DBS (deep brain stimulation)

Delayed Activation - Deep Brain Stimulation (DBS); Immediate Activation - Deep Brain Stimulation (DBS)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Movement Disorders Center

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Okun MS, Foote KD, Wu SS, Ward HE, Bowers D, Rodriguez RL, Malaty IA, Goodman WK, Gilbert DM, Walker HC, Mink JW, Merritt S, Morishita T, Sanchez JC. A trial of scheduled deep brain stimulation for Tourette syndrome: moving away from continuous deep brain stimulation paradigms. JAMA Neurol. 2013 Jan;70(1):85-94. doi: 10.1001/jamaneurol.2013.580.

  PMID: 23044532 DERIVED

Related Links

• Increased Thalamic Gamma Band Activity Correlates with Symptom Relief following Deep Brain Stimulation in Humans with Tourette's Syndrome

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Assistant Director of Clinical Trials
• Organization: University of Florida Center for Movement Disorders & Neurorestoration

stacy.merritt@neurology.ufl.edu

352-294-5000

Study Officials

• Michael Okun, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Programming to be performed for this study by the programming investigator under the supervision of the PI
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective blinded staggered onset design

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: April 5, 2011
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2017
• Last Updated: June 8, 2018
• Results First Posted: May 9, 2014

Record last verified: 2018-06

Locations

US (1)