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

NCT04342754 | Unknown

• 1 other identifier: 3.158.435
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome

Keywords

DBS; Deep Brain Stimulation; Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.

  Assess 5 items: number, frequency, intensity, complexity, interference. Each item is scored for phonic and motor tic symptom by the patient on a 0 to 5 numerical scale. The maximum possible score for these part is 50. Add to that the impairment score, which also has 50 as the maximum score. Total Yale Global Tic Severity Scale Score (Total Tic Severity Score + Impairment). The maximum possible score for the total scale is 100. Lower scores of YGTSS represents less tics.

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

Secondary Outcomes (6)

• Change in psychiatric symptoms - Anxiety

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

• Change in Quality of Life

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

• Change in psychiatric symptom - Depression

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

• Change in psychiatric symptom - obsessive-compulsive disorder

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

• Change in psychiatric symptom - attention deficit hyperactivity disorder

  month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.

Study Arms (2)

Deep Brain Stimulation ON (DBS ON)

EXPERIMENTAL

The device will be turned ON

Device: Deep Brain Stimulation (DBS)

Deep Brain Stimulation OFF (DBS OFF)

SHAM COMPARATOR

The device will be turned OFF

Device: Sham Stimulation

Interventions

Deep Brain Stimulation (DBS) DEVICE

The device will be ON

Deep Brain Stimulation ON (DBS ON)

Sham Stimulation DEVICE

The device will be OFF

Deep Brain Stimulation OFF (DBS OFF)

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Rubens G Cury, MD PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD

Model Details: Phase 1: Open label phase. All patients are in the ON stimulation condition and will be followed for 6 months. Phase 2: Blind phase. All patients will be randomized for ON stimulation or sham stimulation group for 3 months, followed for 1 month of washout and crossover for other group.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 13, 2020
• Study Start: February 27, 2019
• Primary Completion: December 27, 2022
• Study Completion: June 27, 2023
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

BR (1)