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Deep Brain Stimulation in Tourette Syndrome

NCT06388291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-08

No results posted yet for this study

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

Conditions

  • Tourette Syndrome
  • Deep Brain Stimulation

Interventions

DEVICE

Deep Brain Stimulation

ON/OFF stimulation vs OFF/ON stimulation

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University College London Hospitals

    collaborator OTHER

  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER

  • University of Bristol

    collaborator OTHER

  • University of Dundee

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • University Hospital, Rouen

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2025-05-20
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388291 on ClinicalTrials.gov