Phase
Condition
Tic Disorders
Autism
Treatment
Deep Brain Stimulation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients aged 18 and over:
with chronic, severe, treatment refractory Tourette Syndrome, as defined by a YaleGlobal Tic Severity Scale score (YGTSS (global)) >50/100
with failure to respond to a minimum of two antipsychotic drugs prescribedseparately at maximally tolerated doses for a minimum of 6 weeks OR, intolerance ofthese medications causing early cessation due to adverse events
who have provided agreement to participate and written informed consent
Exclusion
Exclusion Criteria:
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-inducedpsychotic disorder; ICD11 6C43.6 Opioid-induced psychotic disorder; ICD11 6C41.6Cannabis-induced psychotic disorder; ICD11 6C42.6 Synthetic cannabinoid-inducedpsychotic disorder; ICD11 6C44.6 Sedative, hypnotic or anxiolytic-induced psychoticdisorder; ICD11 6C45.6 Cocaine-induced psychotic disorder; ICD11 6C46.6Stimulant-induced psychotic disorder including amphetamines, methamphetamine ormethcathinone; ICD11 6C47.6 Synthetic cathinone-induced psychotic disorder; 6C49.5Hallucinogen-induced psychotic disorder; ICD11 6C4B.6 Volatile inhalant-inducedpsychotic disorder; ICD11 6C4C.6 MDMA or related drug-induced psychotic disorder,including MDA; ICD11 6C4D.5 Dissociative drug-induced psychotic disorder includingKetamine or PCP; ICD11 6C4E.6 Psychotic disorder induced by other specifiedpsychoactive 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 bythe physician reviewing eligibility (ICD11 6D10.2).
Disorders of Intellectual Development (defined as moderate intellectual disabilities (ICD11 6A00.1); severe intellectual disabilities (ICD11 6A00.2); profoundintellectual disabilities (ICD11 6A00.3)).
Autism Spectrum Disorders with exception of ICD11 6A02.0 Autism spectrum disorderwithout disorder of intellectual development and with mild or no impairment offunctional language.
Significant cognitive impairment as judged at the discretion of the physicianreviewing eligibility.
Pregnancy or absence of an acceptable method of contraception.
Contraindications to neurosurgery (such as brain abnormalities, haemostasis disorderor contraindication to MRI) or anaesthesia.
Severe intercurrent pathology and any other disease that could interfere with theprotocol 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 cardioverterdefibrillators (ICD), permanent pacemakers (PPM) and drug pumps.
Study Design
Study Description
Connect with a study center
National Hospital of Neurology & Neurosurgery
London,
United KingdomSite Not Available
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