Tourette SyndromeNCT01817517
Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome
A study testing Medtronic Activa Deep Brain Stimulation System in people with Tourette Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being performed to try to understand if the use of deep brain stimulation or DBS can treat the symptoms of Tourette syndrome that do not respond well to current medications. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Medtronic Activa Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 2 Feb 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females who are >=15 years of age. There is no strict age cutoff at the upper limit of inclusion, however subjects may meet the exclusion criteria based on medical contraindications to deep brain stimulation surgery (Points 3. and 6. under the Exclusion Criteria). For subjects in the age range of 15-24 years, an additional Ethics Committee consultation will be obtained prior to offering the subject the required screening visit. This is based on the revised screening criteria now proposed by Shrock, Mink, et al. on studies investigating DBS in TS. Additionally, for subjects in the age range of 15-20, a caregiver will be required to be present for all study visits.
- Subject has a diagnosis of TS as determined by a review of medical records, discussion with referring psychiatrist as well as the DSM-IV criteria and videotaped assessment. This will include an assessment to determine the presence of psychogenic tics, embellishment, factitious symptoms, personality disorders and malingering.
- Subject determined to be treatment-resistant for at least one year prior to the Screening Visit as demonstrated by clinical evidence (determined by review of medical records and discussion with referring psychiatrist or neurologist) of persistent functionally impairing tics that have not responded to treatment with a minimum of three adequate regimens of medication including two failed trials of at least one typical neuroleptic and one atypical neuroleptic medication, along with one failed trial of a first tier medication as defined as follows:
- Adequate trials of one non-neuroleptic medication including drugs from the following (first tier) list: clonidine, guanfacine, topiramate, baclofen, levetiracetam, and clonazepam. Trial failure is defined as demonstrated lack of efficacy or severe side effects.
- Two adequate trials of at least one typical neuroleptic medication (pimozide, fluphenazine, haloperidol) and at least one atypical neuroleptic (risperidone, aripiprazole, ziprasidone, olanzapine, quetiapine). Trial failure is defined as demonstrated lack of efficacy or severe side effects.
- A mandatory trial of behavioral interventions in an attempt to reduce the severity of the tics or comorbid symptoms must also be completed by the subject before offering participation in this trial. This may include habit reversal therapies, stress reduction therapies, or other behavioral therapies under investigation for tic suppression.
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- Subject has both significant vocal and motor tics with a tic subscale score of at least 35 on the YGTSS (Yale Global Tic Severity Scale) at all three Baseline Visits prior to undergoing surgery. For subjects with predominantly vocal tics (and minimal motor) causing significant problems this score requirement will be reduced to 18, similarly for subjects with predominantly motor tics (and minimal vocal) causing significant problems the required score will be 18. A portion of the study team, including the surgeon and two neurologists, will determine by consensus which category the subject falls into and whether the tics are a significant problem.
- All other aspects of the subject's care must be optimized during the preceding 6 months before admission to the study. This includes treatment for comorbid medical, neurological, and psychiatric disorders. Additionally, it includes psychological interventions for any ongoing psychosocial problems the subject may have during the preceding 6 months before study admission.
- Subject must be ambulatory.
- Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device [IUD]). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at baseline Visits 1 and 3.
- Subject is determined by an independent psychiatrist with expertise in capacity assessments to have decision-making capacity to provide informed consent.
- Subject is able to read English, understand and cooperate with study procedures, and has signed a written informed consent form prior to any study procedures.
Who cannot join
- Subject has a positive urine drug screen at any of the three Baseline Visits.
- Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
- Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
- Subject is pregnant or breast-feeding.
- Subject has a history of alcohol or drug abuse within the past 6 months and/or dependence within the past year.
- Subject has a medical illness/condition, and/or abnormal diagnostic finding that would interfere with the completion of the study, confound the results of the study, or pose risk to the patient.
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- Subject has an untreated or uncontrolled Axis I disorder or other major psychiatric disorder including major depression, bipolar disorder, or schizophrenia as determined by the screening psychiatrist.
- Subject has either a current or past history of suicidal plan and/or intent.
- Subject has a tic disorder or other movement disorder attributable to another medical, neurological, or psychiatric disorder other than Tourette Syndrome.
- Subject has a drug-induced tic disorder.
- Subject has significant psychosocial factors that might increase the risk of the DBS procedure or complicate recovery and outcome assessments. (Examples include - history of noncompliance with previous medical and psychosocial treatments, multiple failed medication treatments of inadequate dose or duration, a history of multiple other surgical procedures with poor outcome, unexplained medical history gaps, or pending lawsuits or other legal action.)
- Subject has metal in the head or any other type of implanted stimulator (i.e. cardiac pacemaker, deep brain stimulator for a different disease, spinal cord stimulator, cochlear implant, vagus nerve stimulator, etc.).
- Subject has participated in another investigational drug trial or therapeutic trial within 30 days of Baseline Visit 1.
- Subject has a diagnosis of intellectual disability with documented IQ<70.
- Subject has a neurological condition, or a history of traumatic brain injury associated with loss of consciousness of > 1 hour and/or intracranial/epidural/subdural bleeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Phase 1 Study of Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome
This research is being performed to try to understand if the use of deep brain stimulation or DBS can treat the symptoms of Tourette syndrome that do not respond well to current medications. In order to do this the investigators will place small stimulation leads on both sides of the brain in a region (a portion of the thalamus) that may alter the abnormal activity in the brain contributing to the symptoms of Tourette syndrome. This requires two surgical procedures, and several preoperative and postoperative visits for tuning the stimulation parameters and recording stimulation effects. The FDA has not approved DBS for use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not conducted testing for the system in Tourette syndrome. Therefore its use in this study is experimental.
- Conditions
- Tourette Syndrome
- Being tested
- Medtronic Activa Deep Brain Stimulation System
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Activa Deep Brain Stimulation SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation implant | Experimental | Unblinded treatment arm, thalamic DBS for Tourette syndrome. Receives: Device: Medtronic Activa Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS)
Investigators will assess deep brain stimulation effects on tic frequency and severity using the change in Yale Global Tic Severity Scale (YGTSS) in this population of Tourette syndrome patients. The scales range from 0-100, higher scores indicate greater tic severity and impairment.
Measured: 1 year after neurostimulator implantation
Number of Participants Free of Adverse Device Effects (ADEs).
We will assess the incidence of adverse device effects (ADEs) as defined by the Code of Federal Regulations (21 CFR 812.3) at 1 year. Number of participants free of adverse events by 1year post implantation is reported.
Measured: 1 year after neurostimulator implantation.
Secondary outcomes (2)
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale
We will assess deep brain stimulation effects on obsessive compulsive disorder symptoms using the Yale-Brown Obsessive Compulsive Scale (Baseline score - Final score). Score range 0-40, higher scores indicate greater severity of OCD symptoms.
Measured: 1 year after neurostimulator implantation.
Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS)
We will assess deep brain stimulation effects on ADHD symptoms as measured by the WHO Adult ADHD Self-Report Scale (ASRS).
Measured: 1 year after neurostimulator implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2014
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Expired in IRB
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.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ankur Butala, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817517
- Sponsor's protocol ID
- NA_00073086
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2013
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome
- ClinicalTrials.gov ID
- NCT01817517
- Acronym / sponsor ID
- NA_00073086
- Conditions
- Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expired in IRB
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being performed to try to understand if the use of deep brain stimulation or DBS can treat the symptoms of Tourette syndrome that do not respond well to current medications. In order to do this the investigators will place small stimulation leads on both sides of the brain in a region (a portion of the thalamus) that may alter the abnormal activity in the brain contributing to the symptoms of Tourette syndrome. This requires two surgical procedures, and several preoperative and postoperative visits for tuning the stimulation parameters and recording stimulation effects. The FDA has not approved DBS for use in people with Tourette syndrome, and Medtronic (the manufacturer of the device) has not conducted testing for the system in Tourette syndrome. Therefore its use in this study is experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation implant | Experimental | Device: Medtronic Activa Deep Brain Stimulation SystemUnblinded treatment arm, thalamic DBS for Tourette syndrome. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females who are >=15 years of age. There is no strict age cutoff at the upper limit of inclusion, however subjects may meet the exclusion criteria based on medical contraindications to deep brain stimulation surgery (Points 3. and 6. under the Exclusion Criteria). For subjects in the age range of 15-24 years, an additional Ethics Committee consultation will be obtained prior to offering the subject the required screening visit. This is based on the revised screening criteria now proposed by Shrock, Mink, et al. on studies investigating DBS in TS. Additionally, for subjects in the age range of 15-20, a caregiver will be required to be present for all study visits.
- Subject has a diagnosis of TS as determined by a review of medical records, discussion with referring psychiatrist as well as the DSM-IV criteria and videotaped assessment. This will include an assessment to determine the presence of psychogenic tics, embellishment, factitious symptoms, personality disorders and malingering.
- Subject determined to be treatment-resistant for at least one year prior to the Screening Visit as demonstrated by clinical evidence (determined by review of medical records and discussion with referring psychiatrist or neurologist) of persistent functionally impairing tics that have not responded to treatment with a minimum of three adequate regimens of medication including two failed trials of at least one typical neuroleptic and one atypical neuroleptic medication, along with one failed trial of a first tier medication as defined as follows:
- A mandatory trial of behavioral interventions in an attempt to reduce the severity of the tics or comorbid symptoms must also be completed by the subject before offering participation in this trial. This may include habit reversal therapies, stress reduction therapies, or other behavioral therapies under investigation for tic suppression.
- Subject has both significant vocal and motor tics with a tic subscale score of at least 35 on the YGTSS (Yale Global Tic Severity Scale) at all three Baseline Visits prior to undergoing surgery. For subjects with predominantly vocal tics (and minimal motor) causing significant problems this score requirement will be reduced to 18, similarly for subjects with predominantly motor tics (and minimal vocal) causing significant problems the required score will be 18. A portion of the study team, including the surgeon and two neurologists, will determine by consensus which category the subject falls into and whether the tics are a significant problem.
Key exclusion criteria (15 listed)
- Subject has a positive urine drug screen at any of the three Baseline Visits.
- Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
- Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
- Subject is pregnant or breast-feeding.
- Subject has a history of alcohol or drug abuse within the past 6 months and/or dependence within the past year.
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 |
|---|---|---|
| Medtronic Activa Deep Brain Stimulation System | Device | Deep Brain Stimulation implant |
Primary outcome
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS)
Time frame: 1 year after neurostimulator implantation
Investigators will assess deep brain stimulation effects on tic frequency and severity using the change in Yale Global Tic Severity Scale (YGTSS) in this population of Tourette syndrome patients. The scales range from 0-100, higher scores indicate greater tic severity and impairment.
Number of Participants Free of Adverse Device Effects (ADEs).
Time frame: 1 year after neurostimulator implantation.
We will assess the incidence of adverse device effects (ADEs) as defined by the Code of Federal Regulations (21 CFR 812.3) at 1 year. Number of participants free of adverse events by 1year post implantation is reported.
2 secondary outcomes
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale
Time frame: 1 year after neurostimulator implantation.
Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS)
Time frame: 1 year after neurostimulator implantation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tourette Syndrome
Not yet recruiting
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Deep Brain Stimulation Therapy in Movement Disorders
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
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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.
Ankur Butala, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Activa Deep Brain Stimulation System in people with Tourette Syndrome, run by Johns Hopkins University 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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 Jan 2026. 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 28 Jan 2026). 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?
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) (time frame: 1 year after neurostimulator implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.