Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subthalamic Stimulation in Tourette's Syndrome (STN-DBSinTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619084
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Luigi M. Romito, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.


Condition or disease Intervention/treatment Phase
Tourette's Syndrome Tourette Syndrome Gilles de la Tourette Syndrome Tourette Disorder Procedure: STN DBS Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Subthalamic Nucleus Deep Brain Stimulation in Tourette's Syndrome
Study Start Date : December 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STN DBS ON First
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
Bilateral STN DBS
Other Names:
  • Deep Brain Stimulation of the subthalamic nucleus
  • Neurostimulators: Medtronic Activa® SC 37603
  • Extensions: Medtronic Model 37086
  • Leads: Medtronic Model 3389

Experimental: STN DBS OFF First
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
Bilateral STN DBS
Other Names:
  • Deep Brain Stimulation of the subthalamic nucleus
  • Neurostimulators: Medtronic Activa® SC 37603
  • Extensions: Medtronic Model 37086
  • Leads: Medtronic Model 3389




Primary Outcome Measures :
  1. Change in Yale Global Tic Severity Scale [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]

    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.



Secondary Outcome Measures :
  1. Change in Milan Overall Dementia Assessment (MODA) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects on TS neuropsychological features of STN stimulation. Assessments will be performed by administering the MODA (assessing specific neuropsychological tests, exploring the global deterioration, the executive functions, the working memory and fluency).

  2. Change in brain activity recorded by PET [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    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

  3. STN DBS safety in treating medically-refractory Tourette syndrome [ Time Frame: 24 months ]
    An analysis of adverse and side effects of surgery and STN stimulation will be performed during the whole observation period (24 months)

  4. Change in Yale-Brown Obsessive Compulsive scale (Y-BOCS) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    One of the secondary outcome will measure the effect of STN DBS in controlling obsessive-compulsive features (by evaluating the change on the Y-BOCS) in patients with medically refractory TS

  5. Change in Global assessment scale (GAS). [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the overall functioning of a TS subjects during the specified time period on a continuum from psychological or psychiatric sickness to health. Assessments will be performed by administering the GAS.

  6. Change in Global Clinical Impression Scale (GCI-S) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the overall status of a TS subjects during the specified time period. Assessments will be performed by administering the GCI-S.

  7. Change in Gilles de la Tourette syndrome-quality of life scale (GTS-QOL) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the overall QoL of a TS subjects during the specified time period. Assessments will be performed by administering the GTS-QOL.

  8. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the depressive features of a TS subjects during the specified time period. Assessments will be performed by administering the MADRS.

  9. Change in ADHD Rating Scale-IV (ADHD-RS) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the ADHD symptoms of a TS subjects during the specified time period. Assessments will be performed by administering the ADHD-RS.

  10. Change in Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Three months after stimulation switched ON v pre-operative condition ]
    To evaluate the effects of STN stimulation on the anxiety symptoms of a TS subjects during the specified time period. Assessments will be performed by administering the HAM-A.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619084


Locations
Layout table for location information
Italy
Fondazione IRCCS Istituto neurologico Carlo Besta
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Ministry of Health, Italy
Investigators
Layout table for investigator information
Principal Investigator: Luigi M Romito, MD, PhD IRCCS Istituto Neurologico Carlo Besta, Milano, Italy
Publications:
de la Tourette G. Étude sur une affection nerveuse caractérisée par l'incoordination motrice accompagnée d'écholalie et de coprolalie. Arch Neurol 1885;9:158-200
American Psychiatric Association. DSM-IV-TR Diagnostic and Statistical Manual of Mental Disorders, IV ed. Washington DC and London: 2000

Layout table for additonal information
Responsible Party: Luigi M. Romito, MD, PhD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT02619084    
Other Study ID Numbers: RF-131
GR-2009-1594645 ( Other Grant/Funding Number: Italian Ministry of Health )
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Luigi M. Romito, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta:
Tourette Syndrome
Subthalamic Nucleus
STN
Deep Brain Stimulation
DBS
Tic
Obsessive-compulsive disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders