Tourette Syndrome Deep Brain Stimulation

Summary

The purpose of this study is to evaluate the effectiveness and safety of deep brain stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).

This investigation will (1) test the hypothesis that centromedian (CM) continuous brain stimulation will be an effective, safe method for the treatment of tics in medication refractory TS, (2) will define the intra-operative and post-operative physiological changes, and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an alternative to chronic DBS in TS.

Conditions

• Tourette Syndrome

Interventions

DEVICE

Continuous DBS

The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips. The DBS system will be set to provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether or not the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. These subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS.

DEVICE

Responsive Brain Stimulation (RBS Setting)

The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips. Six months post-surgery, the DBS system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for DBS. Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention.

Sponsors & Collaborators

• Medtronic

  collaborator INDUSTRY

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Michael Okun, MD · University of Florida

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-20

Primary Completion

2021-08-25

Completion

2023-08-24

FDA Device

Yes

Countries

• United States

Study Locations