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Deep Brain Stimulation

Deep Brain Stimulation for Tourette Syndrome

N/A
Waitlist Available
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
Must not have
Subject has an untreated or uncontrolled Axis I disorder or other major psychiatric disorder
Subject has a drug-induced tic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after neurostimulator implantation.
Awards & highlights

Summary

This trial is testing if Deep Brain Stimulation (DBS) can help patients with Tourette syndrome who don't respond to current treatments. DBS uses small devices to send electrical signals to the brain, aiming to calm overactive areas causing symptoms.

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.
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.
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 below
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My condition has not improved with treatment for at least one year.
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I can walk on my own.
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I have been diagnosed with Tourette Syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an untreated major psychiatric disorder.
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I have developed a tic disorder due to medication.
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I have a movement disorder not caused by Tourette Syndrome.
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I have a neurological condition or had a severe head injury with loss of consciousness for more than an hour.
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I had major surgery less than 3 months ago or plan to have surgery soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after neurostimulator implantation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after neurostimulator implantation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the Yale Global Tic Severity Scale (YGTSS)
Incidence of adverse device effects (ADEs).
Secondary study objectives
Change from baseline in the WHO Adult ADHD Self-Report Scale (ASRS)
Change from baseline in the Yale-Brown Obsessive Compulsive Scale
Other study objectives
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 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation implantExperimental Treatment1 Intervention
Unblinded treatment arm, thalamic DBS for Tourette syndrome.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Deep Brain Stimulation (DBS) is a treatment for Tourette Syndrome that involves implanting electrodes in specific brain regions, such as the thalamus, to modulate abnormal neural activity. This is particularly relevant for patients with refractory Tourette Syndrome, where traditional medications are ineffective. By altering the brain's electrical activity, DBS can reduce the frequency and severity of tics, improving the quality of life for patients. Other common treatments include medications that target neurotransmitter systems, such as dopamine antagonists, which help to control tics by balancing chemical signals in the brain. Understanding these mechanisms is crucial for developing effective treatment plans and providing relief to patients.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,899 Total Patients Enrolled
8 Trials studying Tourette Syndrome
299 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
~3 spots leftby Apr 2030
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