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

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.

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.

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.