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

University of Sao Paulo General Hospital

Status

Active, not recruiting

Conditions

Tourette Syndrome

Treatments

Device: Deep Brain Stimulation (DBS)

Device: Sham Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04342754

3.158.435

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 estimated patients

Sex

All

Ages

14 to 100 years old

Volunteers

No 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.