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Contact Information:

Ms Atiyyah Moosa
+44 (0)20 7679 9481
cctu.optics@ucl.ac.uk


Prof Patricia Limousin
+44 (0)203 448 8723
P.Limousin@ucl.ac.uk


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Be Part of Research - Trial Details - Deep brain stimulation in Tourette syndrome
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Deep brain stimulation in Tourette syndrome

Not Recruiting

Open to: All Genders

Age: Adult

London Exeter Salford London

Medical Conditions

Tourette syndrome

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study aims to assess whether deep brain stimulation (DBS) reduces tic severity in patients with disabling Tourette Syndrome (TS). TS is characterised by involuntary movements (motor tics) and vocalisations (vocal tics) that start in childhood. The tics are usually mild and diminish over time but in a small number of people they persist, are severe, debilitating, and unresponsive to conventional treatments. Tics can be extremely forceful, cause serious self-harm and distress and constrain normal life activities. DBS is a technique that involves the surgical implantation of two thin wires, called electrodes, in the right and left globus pallidus, an area of the brain that is responsible for the control of body movement. These electrodes are connected to a stimulator placed on the chest under the skin that sends electrical signals to the brain. This type of surgery has been used since the late 1980s to treat patients with neurological disorders. It is routinely used for disorders such as Parkinson’s disease and has also been used in a smaller number of patients with Tourette Syndrome. The aim of this study is to find out if DBS of the globus pallidus structure of the brain can reduce severe motor or phonic (vocal) tics in patients who suffer from Tourette Syndrome.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2022 30 Jul 2024

Participants will be assessed as being suitable for the study by their Neurologist. They will then be referred by their Neurologist to attend the National Hospital for Neurology and Neurosurgery (NHNN) in London for a pre-screening visit with the multidisciplinary team of neurosurgeons, neurologists, neuropsychiatrists and specialist DBS nurses. The study team at NHNN will need details about the participant’s Tourette Syndrome symptoms, general medical history, medication history and check if there is any reason they would not be able to undergo surgery. If they are suitable to take part in the study, the research team at the NHNN will invite the participant to attend a baseline visit. At this point, the participant will be invited to reconfirm consent to participate in the study. Patients will be admitted to the hospital under the care of a team with expertise in DBS and TS. They will be implanted with a DBS system in a part of the brain known as the "internal pallidum" which has produced the desired effect of tic reduction in previous small studies. Initially, 6 months will be spent adjusting the amplitude of other parameters of stimulation with the aim of optimising the stimulation to make the treatment as beneficial as possible. In previous studies, this phase was not long enough to obtain the best possible outcome. After 6 months, patients will be randomly placed into two groups. One group will be kept with DBS switched on and the other will have DBS switched off for up to 2 weeks. After this period, patients will be reassessed and a few days later will be swapped to the other condition. The patients and doctors doing the assessments will not know if the DBS is switched on or off. This will test, in an unbiased way, whether any tic reduction is specifically due to DBS. From previous experience, the tics are expected to come back within one to two days of DBS being discontinued. Patients who cannot tolerate DBS being switched off for the full 2 weeks will be assessed and the DBS will be turned on again sooner. Patients will have the choice of coming into the hospital for this part of the study.


Patients aged 18 years and over who suffer from severe Tourette Syndrome and have found that conventional treatments, such as medication, do not control their motor or phonic (vocal) tics

You can take part if:



You may not be able to take part if:


1. Schizophrenia or other primary psychotic disorder (schizophrenia (ICD11 6A20); delusional disorders (ICD11 6A24); schizoaffective disorder (ICD11 6A21)2. 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) 3. Recurrent depressive disorder with a history of attempted suicide (ICD11 6A71)4. Bipolar disorder (ICD11 6A60)5. Severe personality disorder judged to be contributing to impaired social function by the physician reviewing eligibility (ICD11 6D10.2)6. Disorders of Intellectual Development (defined as moderate intellectual disabilities (ICD11 6A00.1); severe intellectual disabilities (ICD11 6A00.2); profound intellectual disabilities (ICD11 6A00.3))7. 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 language8. Significant cognitive impairment as judged at the discretion of the physician reviewing eligibility9. Pregnancy or absence of an acceptable method of contraception10. Contraindications to neurosurgery (such as brain abnormalities, haemostasis disorder or contraindication to MRI) or anaesthesia11. Severe intercurrent pathology and any other disease that could interfere with the protocol or compromise life expectancy, in the Investigator’s judgement12. Continued participation in any other interventional clinical trials13. Any other implanted electronic devices such as implantable cardioverter defibrillators (ICD), permanent pacemakers (PPM) and drug pumps


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St George's Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Royal Devon and Exeter NHS Foundation Trust
    Royal Devon & Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Salford Royal Hospital
    Stott Lane Eccles
    Salford
    M6 8HD
  • National Hospital for Neurology & Neurosurgery
    Queen Square
    London
    WC1N 3BG

The DBS device could significantly reduce the severity of participants’ tics and other symptoms. If a significant improvement in symptoms is achieved, this will allow participants to function better than they are currently and may improve their quality of life, allowing more independence. The tics may only improve a little, but nevertheless this small improvement may be beneficial. However, there is no guarantee that DBS will improve tics and other symptoms. The results from this study will provide information to doctors regarding DBS treatment of patients with Tourette Syndrome in the future.
This is a clinical study so the researchers cannot be sure that the treatment will be successful. There is a risk of having to undergo surgery and assessment without improvement of motor or phonic (vocal) tics and other symptoms. There are also risks associated with surgery: the surgical procedure carries a very small risk of bleeding in the brain resulting in a stroke (less than 1 in 500 in our centre, which could lead to paralysis or even theoretically death (never occurred at NHNN) as well as a small risk of infection (about 2%) or seizures (about 1%). Infections can be treated with antibiotics but may need the system to be removed to heal, it can usually be replaced a few months later. Seizures might affect temporarily the ability to hold a driving licence. Other possible disadvantages include periods of hospitalisation that are required for surgery and are optional for the randomised phase. There are a large number of study visits, particularly during the randomised phase if participants decide not to be hospitalised. The study also requires travel to the NHNN in London for study visits and time to complete the questionnaires and scales. Future MRI examinations can only be done once specific conditions are met. Having DBS may mean that participants are not eligible to take part in clinical studies in the future.

Prof Patricia Limousin
+44 (0)203 448 8723
P.Limousin@ucl.ac.uk


Ms Atiyyah Moosa
+44 (0)20 7679 9481
cctu.optics@ucl.ac.uk



The study is sponsored by University College London and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR129340.



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Read full details for Trial ID: ISRCTN17008820

Or CPMS 51655

Last updated 17 July 2024

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