Status:

UNKNOWN

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

Lead Sponsor:

University of Sao Paulo General Hospital

Conditions:

Tourette Syndrome

Eligibility:

All Genders

14-100 years

Phase:

NA

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 refractor...

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 fo...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 27 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 27 2023

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04342754

Start Date

February 27 2019

End Date

June 27 2023

Last Update

June 10 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of São Paulo

São Paulo, São Paulo, Brazil, 05403-000

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