What side effects are associated with this type of intervention?

The most common treatments for Tourette Syndrome, particularly neuromodulation techniques like Deep Brain Stimulation (DBS), can have side effects such as infection, bleeding, hardware complications, and potential changes in mood or cognition. Other neuromodulation methods like transcranial magnetic stimulation (TMS) may cause lightheadedness, tingling, and tinnitus. Pharmacological treatments, including antipsychotics and VMAT2 inhibitors, often lead to sedation, weight gain, and metabolic changes.

What prior FDA approvals exist?

The FDA has not approved Deep Brain Stimulation (DBS) for the treatment of Tourette Syndrome. While DBS is being studied for its potential to alter abnormal brain activity in the thalamus, it remains experimental. Other neuromodulation treatments, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct-current stimulation (tDCS), have shown mixed results in clinical trials but are not specifically FDA-approved for Tourette Syndrome.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation for Tourette Syndrome patients include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). These non-invasive neuromodulation techniques have shown potential in altering brain activity and improving symptoms in various neurological and psychiatric conditions.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after neurostimulator implantation.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Deep Brain Stimulation implantExperimental Treatment1 Intervention

Unblinded treatment arm, thalamic DBS for Tourette syndrome.

0 / 8Eligibility criteria met

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.