Tourette SyndromeNCT04342754
Deep Brain Stimulation in Forel's H Field in Tourette's Syndrome
A study testing Deep Brain Stimulation (DBS) in people with Tourette Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Deep Brain Stimulation (DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2019to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Deep Brain Stimulation of Forel's H Field in Tourette's Syndrome: Prospective, Randomized, Crossover, Double-blind Study
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.
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- Deep Brain Stimulation (DBS), Sham Stimulation
- Keywords
- DBS, Deep Brain Stimulation, Tourette Syndrome
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS)Device
The device will be ON
Sham StimulationDevice
The device will be OFF
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation ON (DBS ON) | Experimental | The device will be turned ON Receives: Device: Deep Brain Stimulation (DBS) |
| Deep Brain Stimulation OFF (DBS OFF) | Sham comparator | The device will be turned OFF Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (6)
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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start27 Feb 2019
- Primary completion27 Dec 2022 (estimated)
- Study completion27 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Gisbert Cury, University of Sao Paulo General Hospital
- Investigators
- Rubens G Cury, MD PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342754
- Sponsor's protocol ID
- 3.158.435
- Status last verified
- Jun 2022
- First submitted
- 1 Apr 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Deep Brain Stimulation of Forel's H Field in Tourette's Syndrome: Prospective, Randomized, Crossover, Double-blind Study
- ClinicalTrials.gov ID
- NCT04342754
- Acronym / sponsor ID
- 3.158.435
- Conditions
- Tourette Syndrome
- Keywords
- DBS, Deep Brain Stimulation, Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 27 Jun 2023 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation ON (DBS ON) | Experimental | Device: Deep Brain Stimulation (DBS)The device will be turned ON |
| Deep Brain Stimulation OFF (DBS OFF) | Sham comparator | Device: Sham StimulationThe device will be turned OFF |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (DBS)The device will be ON | Device | Deep Brain Stimulation ON (DBS ON) |
| Sham StimulationThe device will be OFF | Device | Deep Brain Stimulation OFF (DBS OFF) |
Primary outcome
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.
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.
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.
6 secondary outcomes
Change in psychiatric symptoms - Anxiety
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
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
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Tourette Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens G Cury, MD PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS) in people with Tourette Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.