Clinical trial NCT04342754: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Keywords: DBS
Deep Brain Stimulation
Tourette Syndrome
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 8
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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.
timeFrame: 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:
measure: Change in psychiatric symptoms - Anxiety
timeFrame: 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.
measure: Change in Quality of Life
timeFrame: 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.
measure: Change in psychiatric symptom - Depression
timeFrame: 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.
measure: Change in psychiatric symptom - obsessive-compulsive disorder
timeFrame: 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.
measure: Change in psychiatric symptom - attention deficit hyperactivity disorder
timeFrame: 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.
measure: assessment of structural connectivity patterns
timeFrame: 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.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Rubens G Cury, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: