NCT04342754

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation (DBS)	The device will be ON
DEVICE	Sham Stimulation	The device will be OFF

Timeline

• Start date: 2019-02-27
• Primary completion: 2022-12-27
• Completion: 2023-06-27
• First posted: 2020-04-13
• Last updated: 2022-06-10

Locations

1 site across 1 country: Brazil