Tourette SyndromeOp-TICSNCT06388291
Deep Brain Stimulation in Tourette Syndrome
A study testing Deep Brain Stimulation in people with Tourette Syndrome and Deep Brain Stimulation, run by University College, London at 1 site in United Kingdom.
Trial summary
Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS). It is a randomised, double-blind, crossover clinical investigation for 20 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Deep Brain Stimulation
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 and over:
- with chronic, severe, treatment refractory Tourette Syndrome, as defined by a Yale Global Tic Severity Scale score (YGTSS (global)) >50/100
- with failure to respond to a minimum of two antipsychotic drugs prescribed separately at maximally tolerated doses for a minimum of 6 weeks OR, intolerance of these medications causing early cessation due to adverse events
- who have provided agreement to participate and written informed consent
Who cannot join
- Schizophrenia or other primary psychotic disorder (schizophrenia (ICD11 6A20); delusional disorders (ICD11 6A24); schizoaffective disorder (ICD11 6A21).
- History of substance-induced psychotic disorder (ICD11 6C40.6 Alcohol-induced psychotic disorder; ICD11 6C43.6 Opioid-induced psychotic disorder; ICD11 6C41.6 Cannabis-induced psychotic disorder; ICD11 6C42.6 Synthetic cannabinoid-induced psychotic disorder; ICD11 6C44.6 Sedative, hypnotic or anxiolytic-induced psychotic disorder; ICD11 6C45.6 Cocaine-induced psychotic disorder; ICD11 6C46.6 Stimulant-induced psychotic disorder including amphetamines, methamphetamine or methcathinone; ICD11 6C47.6 Synthetic cathinone-induced psychotic disorder; 6C49.5 Hallucinogen-induced psychotic disorder; ICD11 6C4B.6 Volatile inhalant-induced psychotic disorder; ICD11 6C4C.6 MDMA or related drug-induced psychotic disorder, including MDA; ICD11 6C4D.5 Dissociative drug-induced psychotic disorder including Ketamine or PCP; ICD11 6C4E.6 Psychotic disorder induced by other specified psychoactive substance).
- Recurrent depressive disorder with a history of attempted suicide (ICD11 6A71).
- Bipolar disorder (ICD11 6A60).
- Severe personality disorder judged to be contributing to impaired social function by the physician reviewing eligibility (ICD11 6D10.2).
- Disorders of Intellectual Development (defined as moderate intellectual disabilities (ICD11 6A00.1); severe intellectual disabilities (ICD11 6A00.2); profound intellectual disabilities (ICD11 6A00.3)).
Show all 13Show fewer
- Autism Spectrum Disorders with exception of ICD11 6A02.0 Autism spectrum disorder without disorder of intellectual development and with mild or no impairment of functional language.
- Significant cognitive impairment as judged at the discretion of the physician reviewing eligibility.
- Pregnancy or absence of an acceptable method of contraception.
- Contraindications to neurosurgery (such as brain abnormalities, haemostasis disorder or contraindication to MRI) or anaesthesia.
- Severe intercurrent pathology and any other disease that could interfere with the protocol or compromise life expectancy, in the Investigator's judgement.
- Continued participation in any other interventional clinical trials.
- Any other implanted electronic devices such as implantable cardioverter defibrillators (ICD), permanent pacemakers (PPM) and drug pumps.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Hospital of Neurology & Neurosurgery
London
About this study
Official title: Double Blind Comparison of Optimised Deep Brain Stimulation for Severe Tourette Syndrome
Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).
It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery.
Read more
Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.
The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
Read the detailed description
Tourette syndrome (TS) is a neuropsychiatric disorder with patients exhibiting multiple motor tics and at least one vocal tic. When these tics are distressing, medications or behavioural therapy can be used to control symptoms.
However, there are a small number of patients with very severe tics who are unresponsive to these conventional treatments and suffer a major negative impact on their quality of life. This limits their social interaction and access to most jobs. These patients are in urgent need of more effective treatments.
Deep brain stimulation (DBS) is a technique that involves the surgical implantation of two thin wires (electrodes) in the right and left globus pallidus, areas of the brain responsible for the control of body movement. The electrodes are connected to a stimulator placed on the chest under the skin that sends electrical signals to the brain. This type of surgery is routinely used for disorders such as Parkinson's disease and has also been used in a smaller number of TS patients.
DBS is an accepted treatment for conditions such as Parkinson's disease, dystonia and tremor. In experienced teams the risks associated with the surgery and the device are very low. A small number of patients with Tourette syndrome around the world have benefited from DBS; nevertheless, more evidence is needed before DBS can be made available as an NHS treatment for severely affected patients and NHS England has prioritised this research topic.
- Conditions
- Tourette Syndrome, Deep Brain Stimulation
- Being tested
- Deep Brain Stimulation
- Keywords
- Movement Disorders, Nervous System Diseases, Brain Diseases, Functional Disorder
- Medical subject headings
- Tourette Syndrome, Movement Disorders, Nervous System Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
ON/OFF stimulation vs OFF/ON stimulation
| Study group | Role | What they receive |
|---|---|---|
| ON/OFF-stimulation | Experimental | This group will have the stimulator switched on for two weeks followed by off for two weeks Receives: Device: Deep Brain Stimulation |
| OFF/ ON -stimulation | Experimental | This group will have the stimulator switched off for two weeks followed by on for two weeks Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
To assess whether GPi DBS is effective in reducing severe motor or vocal tics, measured with the Yale Global Tic Severity Scale -Total Tic Severity (YGTSS- TTS) two weeks OFF stimulation vs two weeks ON Stimulation at the end of the double blind randomised crossover blinded phase, i.e., Effect 1 (Visit 5) vs Effect 2 (Visit 7)
Measured: 4 weeks
Secondary outcomes (9)
MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase.
TIC number and severity measured using the Modified Rush Video Rating Scale (MRVRS) at the end of the OFF-stimulation state (Visit 5) versus the end of the ON-stimulation state (Visit 7) in the blinded randomised phase
Measured: 4 weeks
Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1)
TIC number and severity measured using the MRVRS at Baseline 0 and Baseline 1
Measured: 24 weeks
Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1)
TIC number, severity and complexity measured using the YGTSS at Baseline 0 and Baseline 1
Measured: 24 weeks
Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1)
Quality of life measured using the Gilles de la Tourette Syndrome - Quality Of Life (GTS-QoL) questionnaire at baseline 0 and baseline 1
Measured: 24 weeks
Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1)
Severity of obsessions and compulsions measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at baseline 0 and baseline 1
Measured: 24 weeks
Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1)
Severity of depression measured using Beck Depression Index (BDI) at baseline 0 and baseline 1
Measured: 24 weeks
Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1)
Severity of anxiety measured using the Beck Anxiety Index (BAI) at baseline 0 and baseline 1
Measured: 24 weeks
Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1)
Severity of ADHD symptoms and domains of impairment measured using the Barkley Adult ADHD Rating Scale-IV (BAARS-IV) at baseline 0 and baseline 1
Measured: 24 weeks
Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start2 Aug 2022
- Primary completion20 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Crossover
- Model description
- All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator. This will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment. Following these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): for up to two weeks in each condition. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks. A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase. To identify the factors which predict the degree of response to DBS in TS the investigators will be looking at the role of: clinical factors: age, disease duration, tic severity at baseline, co-morbidity, Electrical parameters of stimulation, \& Imaging.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College London Hospitals, Northern Care Alliance NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, University of Bristol, University of Dundee, London School of Hygiene and Tropical Medicine, King's College London, University Hospital, Rouen, Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388291
- Sponsor's protocol ID
- CTU/2018/321
- Acronym
- Op-TICS
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Comparison of Optimised Deep Brain Stimulation for Severe Tourette Syndrome
- ClinicalTrials.gov ID
- NCT06388291
- Acronym / sponsor ID
- Op-TICS / CTU/2018/321
- Conditions
- Tourette Syndrome, Deep Brain Stimulation
- Keywords
- Movement Disorders, Nervous System Diseases, Brain Diseases, Functional Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College London Hospitals, Northern Care Alliance NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, University of Bristol, University of Dundee, London School of Hygiene and Tropical Medicine, King's College London, University Hospital, Rouen, Imperial College London
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).
It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery.
Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.
The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
Detailed description
Tourette syndrome (TS) is a neuropsychiatric disorder with patients exhibiting multiple motor tics and at least one vocal tic. When these tics are distressing, medications or behavioural therapy can be used to control symptoms.
However, there are a small number of patients with very severe tics who are unresponsive to these conventional treatments and suffer a major negative impact on their quality of life. This limits their social interaction and access to most jobs. These patients are in urgent need of more effective treatments.
Deep brain stimulation (DBS) is a technique that involves the surgical implantation of two thin wires (electrodes) in the right and left globus pallidus, areas of the brain responsible for the control of body movement. The electrodes are connected to a stimulator placed on the chest under the skin that sends electrical signals to the brain. This type of surgery is routinely used for disorders such as Parkinson's disease and has also been used in a smaller number of TS patients.
DBS is an accepted treatment for conditions such as Parkinson's disease, dystonia and tremor. In experienced teams the risks associated with the surgery and the device are very low. A small number of patients with Tourette syndrome around the world have benefited from DBS; nevertheless, more evidence is needed before DBS can be made available as an NHS treatment for severely affected patients and NHS England has prioritised this research topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator. This will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment. Following these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): for up to two weeks in each condition. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks. A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase. To identify the factors which predict the degree of response to DBS in TS the investigators will be looking at the role of: clinical factors: age, disease duration, tic severity at baseline, co-morbidity, Electrical parameters of stimulation, \& Imaging.
| Arm | Type | Receives |
|---|---|---|
| ON/OFF-stimulation | Experimental | Device: Deep Brain StimulationThis group will have the stimulator switched on for two weeks followed by off for two weeks |
| OFF/ ON -stimulation | Experimental | Device: Deep Brain StimulationThis group will have the stimulator switched off for two weeks followed by on for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with chronic, severe, treatment refractory Tourette Syndrome, as defined by a Yale Global Tic Severity Scale score (YGTSS (global)) >50/100
- with failure to respond to a minimum of two antipsychotic drugs prescribed separately at maximally tolerated doses for a minimum of 6 weeks OR, intolerance of these medications causing early cessation due to adverse events
- who have provided agreement to participate and written informed consent
Key exclusion criteria (13 listed)
- Schizophrenia or other primary psychotic disorder (schizophrenia (ICD11 6A20); delusional disorders (ICD11 6A24); schizoaffective disorder (ICD11 6A21).
- History of substance-induced psychotic disorder (ICD11 6C40.6 Alcohol-induced psychotic disorder; ICD11 6C43.6 Opioid-induced psychotic disorder; ICD11 6C41.6 Cannabis-induced psychotic disorder; ICD11 6C42.6 Synthetic cannabinoid-induced psychotic disorder; ICD11 6C44.6 Sedative, hypnotic or anxiolytic-induced psychotic disorder; ICD11 6C45.6 Cocaine-induced psychotic disorder; ICD11 6C46.6 Stimulant-induced psychotic disorder including amphetamines, methamphetamine or methcathinone; ICD11 6C47.6 Synthetic cathinone-induced psychotic disorder; 6C49.5 Hallucinogen-induced psychotic disorder; ICD11 6C4B.6 Volatile inhalant-induced psychotic disorder; ICD11 6C4C.6 MDMA or related drug-induced psychotic disorder, including MDA; ICD11 6C4D.5 Dissociative drug-induced psychotic disorder including Ketamine or PCP; ICD11 6C4E.6 Psychotic disorder induced by other specified psychoactive substance).
- Recurrent depressive disorder with a history of attempted suicide (ICD11 6A71).
- Bipolar disorder (ICD11 6A60).
- Severe personality disorder judged to be contributing to impaired social function by the physician reviewing eligibility (ICD11 6D10.2).
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 |
|---|---|---|
| Deep Brain StimulationON/OFF stimulation vs OFF/ON stimulation | Device | OFF/ ON -stimulation, ON/OFF-stimulation |
Primary outcome
Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase
Time frame: 4 weeks
To assess whether GPi DBS is effective in reducing severe motor or vocal tics, measured with the Yale Global Tic Severity Scale -Total Tic Severity (YGTSS- TTS) two weeks OFF stimulation vs two weeks ON Stimulation at the end of the double blind randomised crossover blinded phase, i.e., Effect 1 (Visit 5) vs Effect 2 (Visit 7)
9 secondary outcomes
MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase.
Time frame: 4 weeks
Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1)
Time frame: 24 weeks
Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Tourette Syndrome and Deep Brain Stimulation, run by University College, London at 1 site in United Kingdom.
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 4 inclusion and 13 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 Jul 2025. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase (time frame: 4 weeks). 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 8 Jul 2025.