Tourette Syndrome Clinical Trial
— STN-DBSinTSOfficial title:
Subthalamic Nucleus Deep Brain Stimulation in Tourette's Syndrome
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Istituto neurologico Carlo Besta | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Ministry of Health, Italy |
Italy,
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* Note: There are 47 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Change in Milan Overall Dementia Assessment (MODA) | 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). | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in brain activity recorded by PET | 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 | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | STN DBS safety in treating medically-refractory Tourette syndrome | An analysis of adverse and side effects of surgery and STN stimulation will be performed during the whole observation period (24 months) | 24 months | Yes |
Secondary | Change in Yale-Brown Obsessive Compulsive scale (Y-BOCS) | 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 | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in Global assessment scale (GAS). | 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. | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in Global Clinical Impression Scale (GCI-S) | 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. | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in Gilles de la Tourette syndrome-quality of life scale (GTS-QOL) | 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. | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) | 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. | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in ADHD Rating Scale-IV (ADHD-RS) | 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. | Three months after stimulation switched ON v pre-operative condition | No |
Secondary | Change in Hamilton Anxiety Rating Scale (HAM-A) | 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. | Three months after stimulation switched ON v pre-operative condition | No |
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