protocolSection identificationModule nctId: NCT06388291, orgStudyIdInfo id: CTU/2018/321, briefTitle: Deep Brain Stimulation in Tourette Syndrome, acronym: Op-TICS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: University College London Hospitals, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: St George's University Hospitals NHS Foundation Trust, collaborators name: Royal Devon and Exeter NHS Foundation Trust, collaborators name: University of Bristol, collaborators name: University of Dundee, collaborators name: London School of Hygiene and Tropical Medicine, collaborators name: King's College London, collaborators name: University Hospital, Rouen, collaborators name: Imperial College London, descriptionModule briefSummary: 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, conditionsModule conditions: Tourette Syndrome, conditions: Deep Brain Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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): one group will be kept with the stimulation on ("ON-stimulation") and the other switched off ("OFF-stimulation") for up to two weeks. 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Deep Brain Stimulation, outcomesModule primaryOutcomes 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, secondaryOutcomes measure: MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase., secondaryOutcomes measure: Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events, otherOutcomes measure: A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Hospital of Neurology & Neurosurgery, status: RECRUITING, city: London, country: United Kingdom, contacts name: Patricia Limousin, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False