Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2022-08-02
2025-06-30
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
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.
TREATMENT
TRIPLE
Study Groups
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ON/OFF-stimulation
This group will have the stimulator switched on for two weeks followed by off for two weeks
Deep Brain Stimulation
ON/OFF stimulation vs OFF/ON stimulation
OFF/ ON -stimulation
This group will have the stimulator switched off for two weeks followed by on for two weeks
Deep Brain Stimulation
ON/OFF stimulation vs OFF/ON stimulation
Interventions
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Deep Brain Stimulation
ON/OFF stimulation vs OFF/ON stimulation
Eligibility Criteria
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Inclusion Criteria
1. with chronic, severe, treatment refractory Tourette Syndrome, as defined by a Yale Global Tic Severity Scale score (YGTSS (global)) \>50/100
2. 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
3. who have provided agreement to participate and written informed consent
Exclusion Criteria
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 language.
8. Significant cognitive impairment as judged at the discretion of the physician reviewing eligibility.
9. Pregnancy or absence of an acceptable method of contraception.
10. Contraindications to neurosurgery (such as brain abnormalities, haemostasis disorder or contraindication to MRI) or anaesthesia.
11. Severe intercurrent pathology and any other disease that could interfere with the protocol or compromise life expectancy, in the Investigator's judgement.
12. Continued participation in any other interventional clinical trials.
13. Any other implanted electronic devices such as implantable cardioverter defibrillators (ICD), permanent pacemakers (PPM) and drug pumps.
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University College London Hospitals
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
St George's University Hospitals NHS Foundation Trust
OTHER
Royal Devon and Exeter NHS Foundation Trust
OTHER
University of Bristol
OTHER
University of Dundee
OTHER
London School of Hygiene and Tropical Medicine
OTHER
King's College London
OTHER
University Hospital, Rouen
OTHER
Imperial College London
OTHER
University College, London
OTHER
Responsible Party
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Locations
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National Hospital of Neurology & Neurosurgery
London, , United Kingdom
Countries
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Other Identifiers
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CTU/2018/321
Identifier Type: -
Identifier Source: org_study_id
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