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

NCT ID: NCT04342754

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2023-06-27

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.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Deep Brain Stimulation ON (DBS ON)

The device will be turned ON

Group Type: EXPERIMENTAL

Deep Brain Stimulation (DBS)

Intervention Type: DEVICE

The device will be ON

Deep Brain Stimulation OFF (DBS OFF)

The device will be turned OFF

Group Type: SHAM_COMPARATOR

Sham Stimulation

Intervention Type: DEVICE

The device will be OFF

Interventions

Deep Brain Stimulation (DBS)

The device will be ON

Intervention Type: DEVICE

Sham Stimulation

The device will be OFF

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rubens Gisbert Cury

Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubens G Cury, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

3.158.435

Identifier Type: -

Identifier Source: org_study_id