Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388291
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2022-06-08
Brief Title:
Deep Brain Stimulation in Tourette Syndrome
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Double Blind Comparison of Optimised Deep Brain Stimulation for Severe Tourette Syndrome
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Op-TICS
Brief Summary:
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
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
Detailed Description:
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 of 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 Parkinsons disease and has also been used in a smaller number of TS patients
DBS is an accepted treatment for conditions such as Parkinsons disease dystonia and tremor In experienced teams the risks associated with the surgery and the device are very low A small number of patients with Tourette syndrome around the world have benefited from DBS nevertheless more evidence is needed before DBS can be made available as an NHS treatment for severely affected patients and NHS England has prioritised this research topic
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 of 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 Parkinsons disease and has also been used in a smaller number of TS patients
DBS is an accepted treatment for conditions such as Parkinsons disease dystonia and tremor In experienced teams the risks associated with the surgery and the device are very low A small number of patients with Tourette syndrome around the world have benefited from DBS nevertheless more evidence is needed before DBS can be made available as an NHS treatment for severely affected patients and NHS England has prioritised this research topic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None