Op-TICS
Research type
Research Study
Full title
Double blind comparison of optimised Deep Brain Stimulation for severe Tourette syndrome (Op-TICS)
IRAS ID
300541
Contact name
Patricia Limousin
Contact email
Sponsor organisation
University College London Comprehensive Clinical Trials Unit
ISRCTN Number
ISRCTN17008820
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Tourette syndrome (TS) is a neuropsychiatric disorder with patients exhibiting multiple motor tics and at least one vocal tic. When these tics are distressing, medications or behavioural therapy can be used to control symptoms. 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 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.
Op-TICS will be performed at the National Hospital for Neurology & Neurosurgery and is a clinical investigation of the use of DBS, with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from TS. It is a randomised, double-blind, crossover clinical investigation for 20 patients. 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.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0052
Date of REC Opinion
10 Feb 2022
REC opinion
Further Information Favourable Opinion