Tourette SyndromeNCT01329198
Brain Stimulation for the Treatment of Tourette Syndrome
A study testing NeuroPace RNS® System Deep Brain Stimulator in people with Tourette Syndrome, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- NeuroPace RNS® System Deep Brain Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Movement Disorders Center
Gainesville, Florida, 32611
About this study
Official title: Scheduled and Responsive Brain Stimulation for the Treatment of Tourette Syndrome
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).
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- NeuroPace RNS® System Deep Brain Stimulator
- Keywords
- tourette, tourette's, TS, tourette syndrome, tourette's syndrome
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroPace RNS® System Deep Brain StimulatorDevice
Also called NeuroPace DBS (deep brain stimulation)
Utilizes a signal that the device detects and will respond to with an electrical pre-defined pulse if the signal is encountered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: NeuroPace RNS® System Deep Brain Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 Months
Secondary outcomes (1)
Correlation of Tics and Neural Physiology
Electrical recordings of electroencephalography activity were taken from each subject's implanted leads at each visit from baseline to 6 months. At baseline, the recordings were taken with the device in the off state (not stimulating), while at the 6 month visits the recordings were taken with the subject's device set to optimal parameters for tic control. Using Pearson's correlation coefficient, the variations in frequency and power which were observed were correlated with the Yale Global Tic Severity (YGTSS) scores obtained during primary outcome testing.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective blinded staggered onset design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Okun, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329198
- Sponsor's protocol ID
- 414-2008- A
- Status last verified
- Jun 2018
- First submitted
- 25 Mar 2011
- Last updated
- 8 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 23044532
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheduled and Responsive Brain Stimulation for the Treatment of Tourette Syndrome
- ClinicalTrials.gov ID
- NCT01329198
- Acronym / sponsor ID
- 414-2008- A
- Conditions
- Tourette Syndrome
- Keywords
- tourette, tourette's, TS, tourette syndrome, tourette's syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Posted 9 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective blinded staggered onset design
| Arm | Type | Receives |
|---|---|---|
| Delayed Activation - Deep Brain Stimulation (DBS) | Active comparator | Device: NeuroPace RNS® System Deep Brain StimulatorDelayed 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. |
| Immediate Activation - Deep Brain Stimulation (DBS) | Active comparator | Device: NeuroPace RNS® System Deep Brain StimulatorActive 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroPace RNS® System Deep Brain StimulatorAlso: NeuroPace DBS (deep brain stimulation)Utilizes a signal that the device detects and will respond to with an electrical pre-defined pulse if the signal is encountered. | Device | Delayed Activation - Deep Brain Stimulation (DBS), Immediate Activation - Deep Brain Stimulation (DBS) |
Primary outcome
Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented
Time frame: Baseline to 6 Months
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.
1 secondary outcome
Correlation of Tics and Neural Physiology
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23044532Okun 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.
- Increased Thalamic Gamma Band Activity Correlates with Symptom Relief following Deep Brain Stimulation in Humans with Tourette's SyndromeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Okun, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroPace RNS® System Deep Brain Stimulator in people with Tourette Syndrome, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented (time frame: Baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.