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Device

DBS System for Tourette Syndrome

N/A
Waitlist Available
Led By Michael Okun, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months post-surgery
Awards & highlights

Study Summary

This trial will test if a new treatment, deep brain stimulation (DBS), is effective and safe for treating Tourette Syndrome (TS).

Eligible Conditions
  • Tourette Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between increase in gamma oscillations and improvement in TS symptomatology
Reduction in total tics on the YGTSS after 24 months as an effect of centromedian (CM) continuous DBS stimulation
Reduction in total tics on the Yale Global Tic Severity Scale (YGTSS) after 6 months as an effect of centromedian (CM) continuous DBS stimulation
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation (DBS)Experimental Treatment2 Interventions
Subjects' DBS surgical intervention requires implantation of a DBS system: two CM thalamic leads (one in each brain hemisphere), two ECOG strip leads (one in each brain hemisphere), and two neurostimulators implanted in the chest. The ECOG strip lead is implanted into the brain to provide an interface through which stimulation can be delivered or activity of the brain can be monitored by the device, or observed by a clinician using a programmer. Neurostimulator and leads system includes a programmer, which includes a wand and telemetry interface, and a patient remote control to check battery status and whether the device is on or off. The programmer is used to set up the device, including setup of stimulation and recording, as well as to retrieve data for subsequent review.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,339 Previous Clinical Trials
717,345 Total Patients Enrolled
7 Trials studying Tourette Syndrome
132 Patients Enrolled for Tourette Syndrome
National Science FoundationUNKNOWN
1 Previous Clinical Trials
13 Total Patients Enrolled
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,226 Total Patients Enrolled
1 Trials studying Tourette Syndrome
5 Patients Enrolled for Tourette Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment currently in the process of enlisting participants?

"The information on clinicaltrials.gov reveals that, while it was initially published in May 2014 and updated most recently in December 2021, this medical trial is not actively recruiting patients at the moment. However, there are presently 1404 other trials open to enrollment nationwide."

Answered by AI
Recent research and studies
JAMA NeurologyJournal
Embedded Human Closed-loop Deep Brain Stimulation for Tourette Syndrome
Cagle, Jackson N., Michael S. Okun, Stephanie Cernera, Robert S. Eisinger, Enrico Opri, Dawn Bowers, Herbert Ward, Kelly D. Foote, and Aysegul Gunduz. 2022. “Embedded Human Closed-loop Deep Brain Stimulation for Tourette Syndrome”. JAMA Neurology. American Medical Association (AMA). doi:10.1001/jamaneurol.2022.2741.
clinicaltrials.govStudy
Tourette Syndrome Deep Brain Stimulation
2014. "Tourette Syndrome Deep Brain Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02056873.
All > Tourette Syndrome
~1 spots leftby Apr 2025
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