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Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome

Primary Purpose

Tourette Syndrome

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Deep Brain Stimulation (DBS)
Sham Stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring DBS, Deep Brain Stimulation, Tourette Syndrome

Eligibility Criteria

14 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Tourette's Syndrome diagnosis.
  • Age equal to or above 14 years.
  • Severe impairment of motor tics (Yale Global Tic Severity Scale ≥ 35/50).
  • Patients who are refractory to drug treatment.
  • Patients intellectually able to understand and sign the consent form.
  • Possibility to adhere to research and periodic medical visits after surgery.

Exclusion Criteria:

  • Inability to consent to your participation in the study.
  • Patients with non-stabilized psychiatric comorbidities, such as anxiety and depression.
  • Concomitant treatment with other experimental drugs.
  • Women who are pregnant or breastfeeding.
  • Patients undergoing previous neurosurgical procedures for the treatment of Tourette's Syndrome.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Deep Brain Stimulation ON (DBS ON)

Deep Brain Stimulation OFF (DBS OFF)

Arm Description

The device will be turned ON

The device will be turned OFF

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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'.
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.
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.
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).
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.

Full Information

First Posted
April 1, 2020
Last Updated
June 7, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04342754
Brief Title
Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome
Official Title
Bilateral Deep Brain Stimulation of Forel's H Field in Tourette's Syndrome: Prospective, Randomized, Crossover, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
December 27, 2022 (Anticipated)
Study Completion Date
June 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
DBS, Deep Brain Stimulation, Tourette Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Phase 1: Open label phase. All patients are in the ON stimulation condition and will be followed for 6 months. Phase 2: Blind phase. All patients will be randomized for ON stimulation or sham stimulation group for 3 months, followed for 1 month of washout and crossover for other group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation ON (DBS ON)
Arm Type
Experimental
Arm Description
The device will be turned ON
Arm Title
Deep Brain Stimulation OFF (DBS OFF)
Arm Type
Sham Comparator
Arm Description
The device will be turned OFF
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation (DBS)
Intervention Description
The device will be ON
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
The device will be OFF
Primary Outcome Measure Information:
Title
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.
Description
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.
Secondary Outcome Measure Information:
Title
Change in psychiatric symptoms - Anxiety
Description
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.
Title
Change in Quality of Life
Description
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.
Title
Change in psychiatric symptom - Depression
Description
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.
Title
Change in psychiatric symptom - obsessive-compulsive disorder
Description
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.
Title
Change in psychiatric symptom - attention deficit hyperactivity disorder
Description
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.
Title
assessment of structural connectivity patterns
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Tourette's Syndrome diagnosis. Age equal to or above 14 years. Severe impairment of motor tics (Yale Global Tic Severity Scale ≥ 35/50). Patients who are refractory to drug treatment. Patients intellectually able to understand and sign the consent form. Possibility to adhere to research and periodic medical visits after surgery. Exclusion Criteria: Inability to consent to your participation in the study. Patients with non-stabilized psychiatric comorbidities, such as anxiety and depression. Concomitant treatment with other experimental drugs. Women who are pregnant or breastfeeding. Patients undergoing previous neurosurgical procedures for the treatment of Tourette's Syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens G Cury, MD PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome

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