Tourette syndrome Mental and Behavioural Disorders Combined vocal and multiple motor tic disorder [de la Tourette]
Conditions
Interventions
Op-TICS is an early phase, randomised, double-blind, crossover clinical investigation.
Following consent, at baseline 0, participants will be asked to complete several questionnaires and rating scale
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years and over 2. Chronic, severe, treatment-refractory Tourette syndrome, as defined by a Yale Global Tic Severity Scale score (TGTSS (global)) >50/100 3. 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 4. Provided agreement to participate and written informed consent
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tic severity measured by the Yale Global Tic Severity Scale (YGTSS) – Total Tic Score at the end of the OFF-stimulation state versus the end of the ON-stimulation state at the end of the blinded randomised phase of the clinical investigation, i.e., Effect 1 (visit 5) vs Effect 2 (visit 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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 2. TIC number and severity measured using the MRVRS at baseline 0 and baseline 1 3. TIC number severity and complexity measured using the YGTSS at baseline 0 and baseline 1 4. Quality of life measured using the Gilles de la Tourette Syndrome – Quality Of Life (GTS-QoL) questionnaire at baseline 0 and baseline 1 5. Severity of obsessions and compulsions measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at baseline 0 and baseline 1 6. Severity of depression measured using the Beck Depression Index (BDI) at baseline 0 and baseline 1 7. Severity of anxiety measured using the Beck Anxiety Index (BAI) at baseline 0 and baseline 1 8. 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 9. Safety of DBS indicated by adverse events and serious adverse events at all timepoints throughout the trial Mechanistic outcomes: 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 researchers will be looking at the role of: 1. Clinical factors: age, disease duration, tic severity at baseline (MRVRS), comorbidity (i.e. Y-BOCS, BDI, BAI and BAARS-IV) at baseline 0 (visit 1) and baseline 1 (visit 4) 2. Electrical parameters of stimulation (total electrical energy delivered and volume of tissue activated by stimulation) measured using optimised parameters used for the double-blind phase (visits 4, 5, 6 and 7) 3. Imaging (contact position and relation with anatomic structures and MRI brain connectivity maps as previously done in patients with Parkinson’s disease undergoing DBS) at baseline 0 (visit 1) and | — |
Countries
England, United Kingdom
Contacts
Public ContactAtiyyah Moosa
Outcome results
None listed