Using Deep Brain Stimulation to Treat Tourette Syndrome

Double Blind Comparison of Optimised Deep Brain Stimulation for Severe Tourette Syndrome

This study is testing whether Deep Brain Stimulation can help reduce severe tics in people with Tourette Syndrome who haven't found relief with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University College, London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06388291 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the effectiveness of Deep Brain Stimulation (DBS) in reducing severe motor and vocal tics in patients with Tourette Syndrome (TS). The study involves a randomized, double-blind, crossover design with 20 participants, who will first undergo an open adjustment phase for 6 months to optimize the stimulation settings. Following this, participants will alternate between 2 weeks of stimulation ON and 2 weeks OFF in a randomized order to assess the impact on tic severity using the Yale Global Tic Severity Scale. The goal is to provide more effective treatment options for patients who have not responded to conventional therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with chronic, severe, treatment-refractory Tourette Syndrome.

Not a fit: Patients with primary psychotic disorders or those who have not failed multiple antipsychotic treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the severity of tics in patients with Tourette Syndrome, improving their quality of life.

How similar studies have performed: While DBS has shown promise in a small number of Tourette Syndrome patients, more evidence is needed to establish its efficacy as a standard treatment.

Eligibility criteria

Inclusion Criteria:

Adult patients aged 18 and over:

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:

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.

Where this trial is running

London

• National Hospital of Neurology & Neurosurgery — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Atiyyah Moosa

Conditions Tourette Syndrome; Deep Brain Stimulation; Movement Disorders; Nervous System Diseases; Brain Diseases; Functional Disorder