NCT01329198

Brain Stimulation for the Treatment of Tourette Syndrome

Scheduled and Responsive Brain Stimulation for the Treatment of Tourette Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine whether a particular type of Deep Brain Stimulation (DBS), scheduled Deep Brain stimulation (SBS), is an effective and safe treatment for Tourettte syndrome (TS). The trial will also examine the brain activity associated with TS and tics and explore the possibility of responsive brain stimulation (RBS).

Detailed description

DBS is a surgical procedure that seeks to change the brain's electrical signalling by means of applied electrical current. To this end, a wire with tiny stimulating electrodes is implanted into one or both sides of the brain. An electrode is a small piece of metal used to take an electric current to or from a power source. These electrodes are connected under the skin on the scalp to a small electrical unit called an INS (implantable neurostimulator), which is similar to a heart pacemaker. The device sends out electrical impulses that appear to change the normal flow of electricity in the brain. The wires which house the electrodes will be implanted on both sides of the brain oriented towards the centromedian thalamus-parafascicular complex. This region of the brain has to date the greats number of documented cases revealing significant improvements in motor tics. This region of the brain will also provide a target where physiological changes related to motor tics are likely to be discovered. The device we propose for this study has several features that make it more suitable for use in the TS population than other devices. It is self-contained in the skull and brain, and contains no tunneled neck connector wire and no chest pacemaker deice. This will help to lessen infection, and will assist in limiting device-related fractures due to tics involving neck region. Also, the system can record electro-encephalograph data from the area of the electrodes, which will assist us in gathering information about what specific physiological changes are correlated with tics.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DEVICE	NeuroPace RNS® System Deep Brain Stimulator	Utilizes a signal that the device detects and will respond to with an electrical pre-defined pulse if the signal is encountered.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-11-01
• Completion: 2017-04-01
• First posted: 2011-04-05
• Last updated: 2018-06-08
• Results posted: 2014-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study