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Deep Brain Stimulation
Deep Brain Stimulation for Tourette Syndrome
N/A
Recruiting
Led By Shannon L Dean, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject determined to be treatment-resistant for at least one year prior to the Screening Visit
Subject must be ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after neurostimulator implantation.
Awards & highlights
Study Summary
This trial is testing whether or not placing electrical leads in specific areas of the brain can help to relieve symptoms of Tourette Syndrome that don't respond well to current medications.
Who is the study for?
This trial is for males and females aged 15 or older with severe Tourette Syndrome that hasn't improved with medication. Participants need a significant tic score, be able to walk, understand English, give informed consent, and use birth control if applicable. It's not for those who've had recent major surgery, are pregnant/breastfeeding, have metal implants in the head or other disqualifying medical conditions.Check my eligibility
What is being tested?
The study tests whether deep brain stimulation (DBS) using the Medtronic Activa System can alleviate symptoms of treatment-resistant Tourette Syndrome. The procedure involves implanting small leads into part of the thalamus in the brain through two surgeries followed by visits to adjust and monitor stimulation effects.See study design
What are the potential side effects?
Potential side effects include risks associated with brain surgery such as infection or bleeding at the site of implantation, headache, seizures, changes in mood or behavior; hardware complications like lead displacement; and possible unknown long-term effects since DBS isn't FDA-approved for Tourette Syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has not improved with treatment for at least one year.
Select...
I can walk on my own.
Select...
I have been diagnosed with Tourette Syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after neurostimulator implantation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after neurostimulator implantation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the Yale Global Tic Severity Scale (YGTSS)
Incidence of adverse device effects (ADEs).
Secondary outcome measures
Change from baseline in the WHO Adult ADHD Self-Report Scale (ASRS)
Change from baseline in the Yale-Brown Obsessive Compulsive Scale
Other outcome measures
Change from baseline in the Grooved Pegboard test
Change from baseline in the Hopkins Verbal Learning Test
Change from baseline in the Judgement of Line Orientation
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation implantExperimental Treatment1 Intervention
Unblinded treatment arm, thalamic DBS for Tourette syndrome.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,155 Total Patients Enrolled
7 Trials studying Tourette Syndrome
175 Patients Enrolled for Tourette Syndrome
Shannon L Dean, MD, PhDPrincipal InvestigatorThe Johns Hopkins University School of Medicine, Kennedy Krieger Institute
Media Library
Tourette Syndrome Patient Testimony for trial: Trial Name: NCT01817517 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can the clinical trial accommodate?
"Affirmative. Clinicaltrials.gov has this research project listed as actively recruiting, having been initiated on March 1st 2014 and lastly updated on May 10th 2022. The trial is expected to involve a total of ten participants across one medical site."
Answered by AI
Are new participants welcomed in this research program?
"Yes, the clinicaltrials.gov database confirms that this trial is still open for participants to enrol in. It was initially posted on March 1st 2014 and has been recently updated on May 10th 2022; as a result, it seeks out 10 patients from one specific site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
The Johns Hopkins Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
How long will I be out of work if I am selected? Am I still eligible if I live in Dallas, TX?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I've been suffering from Tourette's Syndrome since I was very young, and it only seems to be getting worse with age. I've done quite a bit of research on Tourette's, and I'm optimistic this could actually work for me. I have ADHD and OCD as well, which gets worse when my Tourette's is acting up. I work full-time for SMU Meadows School of the Arts as the coordinator of the Film & Media Arts division, and I'm also in the process of finishing my MFA so I can teach there too. My Tourette's and ADHD has started to affect my work and schooling in that people are now noticing it and asking me if I'm okay. I can still work just fine, it's just that simple tasks can be difficult at times. Not to mention that over the years I've had pain in my shoulders, back and wrists due to excessive motor tics in those areas. At this point, I'll try anything. I am also very familiar with Medtronic devices and trust the technology.
PatientReceived 1 prior treatment
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