Subthalamic Stimulation in Tourette's Syndrome

NCT02619084 | Completed Phase 2

• 2 other identifiers: RF-131GR-2009-1594645
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory Tourette's syndrome (TS). Secondary objectives are to individuate and standardize the best electrical parameters for STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to correlate the improvement of TS motor and non-motor symptoms to the modification in brain activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the safety of STN DBS in TS patients.

Conditions

Tourette's Syndrome; Tourette Syndrome; Gilles de la Tourette Syndrome; Tourette Disorder

Keywords

Tourette Syndrome; Subthalamic Nucleus; STN; Deep Brain Stimulation; DBS; Tic; Obsessive-compulsive disorders

Outcome Measures

Primary Outcomes (1)

• Change in Yale Global Tic Severity Scale

  Primary outcome measure will evaluate the efficacy of subthalamic nucleus deep brain stimulation (STN DBS) in controlling motor and phonic tics (by evaluating the reduction on the Yale Global Tic Severity Scale - YGTSS) in patients with medically refractory Tourette syndrome (TS), in a study to be performed according a randomized, double-blind, crossover design with two 3-month phases, during which the stimulation could be switched "on" or "off", separated by a 1-month washout period. The assumption tested is that of a meaningful tic improvement by bilateral STN DBS (considered as ≥ 50% reduction in Yale Global Tic Severity Scale - YGTSS from baseline to post-implant in the active stimulation group). YGTSS is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics.

  Three months after stimulation switched ON v pre-operative condition

Secondary Outcomes (10)

• Change in Milan Overall Dementia Assessment (MODA)

  Three months after stimulation switched ON v pre-operative condition

• Change in brain activity recorded by PET

  Three months after stimulation switched ON v pre-operative condition

• STN DBS safety in treating medically-refractory Tourette syndrome

  24 months

• Change in Yale-Brown Obsessive Compulsive scale (Y-BOCS)

  Three months after stimulation switched ON v pre-operative condition

• Change in Global assessment scale (GAS).

  Three months after stimulation switched ON v pre-operative condition

Study Arms (2)

STN DBS ON First

EXPERIMENTAL

The study will be performed according a randomized, double-blind, crossover design with two 3-month phases, during which the stimulation could be switched "on" or "off", separated by a 1-month washout period, At the end of the second double-blind phase, a further open period of 6 months with stimulation switched "on" will follow.

Procedure: STN DBS

STN DBS OFF First

EXPERIMENTAL

The study will be performed according a randomized, double-blind, crossover design with two 3-month phases, during which the stimulation could be switched "on" or "off", separated by a 1-month washout period, At the end of the second double-blind phase, a further open period of 6 months with stimulation switched "on" will follow.

Procedure: STN DBS

Interventions

STN DBS PROCEDURE

Bilateral STN DBS

Also known as: Deep Brain Stimulation of the subthalamic nucleus, Neurostimulators: Medtronic Activa® SC 37603, Extensions: Medtronic Model 37086, Leads: Medtronic Model 3389

STN DBS OFF First; STN DBS ON First

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age at least of 18 years (with potential exceptions)
• Diagnosis of TS based on the diagnostic criteria of the Tourette Syndrome Classification Study Group
• A Yale Tic Global Severity Scale (YTGSS) \> 35/50 for at least 12 months, with tic severity documented by a standardized videotape assessment
• Inadequate response to standard drug treatment or botulinum toxin

You may not qualify if:

• Diagnosis of secondary tic disorder, of heredodegenerative or neurometabolic diseases or history of toxic exposures or encephalitis
• Previous surgery for TS (with potential exceptions)

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Fondazione IRCCS Istituto neurologico Carlo Besta

Milan, Milan, 20133, Italy

Location

Related Publications (47)

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MeSH Terms

Conditions

Tourette Syndrome; Tics; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anxiety Disorders

Study Officials

• Luigi M Romito, MD, PhD

  IRCCS Istituto Neurologico Carlo Besta, Milano, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: December 2, 2015
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

IT (1)