An interventional study of Deep Brain Stimulation (DBS) and Sham Stimulation in Tourette Syndrome, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 14 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-10.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
Tourette's Syndrome (TS) is a neurodevelopmental disease characterized tics that start before the age of 18 years. About 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. Our hypothesis is that DBS in Forel's H Field could improve tourette's symptoms, neurological and psychiatric ones.
Sixteen patients with TS will be included in our protocol. The tics must have a negative influence in the quality of life of these patients. Patients will be submitted to a neuronavigation protocol for the precise location of the surgical target. After the surgery all patients will have the device turned ON for 6 months.
After the first 6 months participants will be randomly in two groups, one to stay with device ON or turned OFF at a period of 3 months. After that the groups will cross over for more 3 months. Clinical and video evaluations will be conducted before the surgery, at end of open fase, in the moment of cross over and at end of all.
225 studies on the registry are indexed under Tourette Syndrome; 36 are open to participants now.
This study's planned enrollment of 8 is below the median of 34 across 170 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →University of Sao Paulo General Hospital is the lead sponsor of 608 studies on the registry; 97 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The device will be turned ON
Device: Deep Brain Stimulation (DBS)
The device will be turned OFF
Device: Sham Stimulation
The device will be ON
The device will be OFF
Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.
Assess 5 items: number, frequency, intensity, complexity, interference. Each item is scored for phonic and motor tic symptom by the patient on a 0 to 5 numerical scale. The maximum possible score for these part is 50. Add to that the impairment score, which also has 50 as the maximum score. Total Yale Global Tic Severity Scale Score (Total Tic Severity Score + Impairment). The maximum possible score for the total scale is 100. Lower scores of YGTSS represents less tics.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Change in psychiatric symptoms - Anxiety
To assess the influence of deep brain stimulation on anxiety by comparing specific scales for the quantitative assessment of this symptom. The scale used is Beck Anxiety Inventory (BAI), a self-report measure of anxiety and total score is calculated by finding the sum of the 21 items.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Change in Quality of Life
Percent change in the score of Gilles de la Tourette Syndrome - Quality of Life scale (GTS-QOL) comparing baseline, device On and device OFF conditions. The GTS-QOL consisted of 27 items and four subscales (psychological, physical, obsessive compulsive and cognitive. Each item is rated across five response options: 'Never', 'Rarely', 'Sometimes', 'Often', 'Always'.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Change in psychiatric symptom - Depression
To assess the influence of deep brain stimulation on depression by comparing specific scales for the quantitative assessment of this symptoms. The scale used is the Beck Depression Inventory (BDI), a 21 item self-rated scale that evaluates key symptoms of depression.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Change in psychiatric symptom - obsessive-compulsive disorder
To assess the influence of deep brain stimulation on obsessive-compulsive disorder (OCD) by comparing specific scales for the quantitative assessment of this symptoms. The scale used is Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a widely used clinician-rated measure for assessing obsessive-compulsive symptoms.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Change in psychiatric symptom - attention deficit hyperactivity disorder
To assess the influence of deep brain stimulation on attention deficit hyperactivity disorder (ADHD) by comparing specific scales for the quantitative assessment of this symptom.The scale used is Adult Self-Report Scale (ASRS-18).
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
assessment of structural connectivity patterns
To assess the variation in the clinical response depending on the pattern of structural connectivity presented by accessing imaging tests of white matter tracts potentially stimulated through ECP targeting the Forel H field.
Time frame: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Plan to share: Undecided
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