Deep Brain Stimulation for Tourette Syndrome

Overseen By Emily Rafferty, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Dopamine blockers, Alpha-2 agonists

Must not be taking: Stimulants, Anticonvulsants

Disqualifiers: Previous neurosurgery, Untreated anxiety, Severe comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that may help people with severe Tourette Syndrome (TS) who haven't found relief from medications. The Medtronic Percept Neurostimulator, implanted in the brain, detects and reduces involuntary movements or sounds, known as tics. It targets individuals whose tics severely disrupt daily life and who have tried multiple medications without success. Eligible participants likely have severe TS confirmed by specialists and have not benefited from other treatments like medication or therapy. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those with severe TS.

Do I have to stop taking my current medications for the trial?

The trial requires that you keep your Tourette Syndrome medications stable and unchanged throughout the study. If you have stopped taking TS medications, you must be stabilized for three months off them before participating.

What prior data suggests that the Medtronic Percept Neurostimulator is safe for use in treating Tourette Syndrome?

Research has shown that the Medtronic Percept Neurostimulator is generally safe for people. The FDA has approved this device for five conditions: Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder (OCD), and epilepsy, indicating a strong safety record.

Some individuals have reported side effects, usually mild, such as temporary tingling or discomfort at the implantation site. Serious side effects are rare. The device employs advanced technology to monitor brain activity, enabling doctors to tailor treatment to each person.

Overall, the Medtronic Percept Neurostimulator has been widely used and studied, demonstrating a good safety record for various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medtronic Percept Neurostimulator for Tourette Syndrome because it offers a unique approach by not only delivering deep brain stimulation but also recording brain signals. Unlike standard treatments like behavioral therapy and medications that often target neurotransmitters, this device uses a control algorithm to adjust stimulation based on real-time brain activity. This personalized approach could potentially lead to more effective and precise management of Tourette symptoms, offering hope for those who haven't found relief with traditional methods.

What evidence suggests that the Medtronic Percept Neurostimulator is effective for Tourette Syndrome?

Research has shown that the Medtronic Percept Neurostimulator, which participants in this trial will receive, can help reduce tics in people with severe Tourette Syndrome. This device targets specific brain areas to calm the activity causing tics. Some studies found that patients experienced improvements in both obsessive-compulsive disorder and Tourette Syndrome with this treatment. Although primarily approved for conditions like Parkinson’s disease and epilepsy, early results are promising for Tourette Syndrome as well. The device sends tiny electrical signals to the brain to help control symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

Aysegul Gunduz, PhD

Principal Investigator

University of Florida

Michael Okun, MD

Principal Investigator

University of Florida

Christopher Butson, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults with severe Tourette Syndrome (TS) that's not improved with medication. They must have a confirmed diagnosis by specialists, stable mental health if they have depression, and a significant impact on their life due to TS. Pregnant women or those planning pregnancy during the study are excluded, as well as individuals with drug-induced tics, recent suicide attempts or substance abuse, metal in the head, previous brain surgery, or other serious health issues.

Inclusion Criteria

I have been diagnosed with Tourette Syndrome by both a specialized neurologist and a psychiatrist.

I will try botulinum toxin treatment for my localized tic before considering surgery.

Must be willing to keep TS related medications stable and unchanged throughout the trial.

Exclusion Criteria

I haven't attempted suicide, abused substances, or had multiple failed medication treatments in the last six months.

I experience severe mental health issues or only have simple body movements.

I have not had brain surgery, metal implants in my head, or any type of implanted stimulator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Monitoring

Participants are implanted with the Medtronic Percept PC device and monitored for tic detection and suppression

6 months

Regular in-person visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after the implantation and monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Percept Neurostimulator

Trial Overview

The trial tests an FDA-approved device called 'Medtronic Percept PC', which is implanted into the brain to detect and suppress tic symptoms in TS patients. It targets specific areas of the brain and records neural signals to understand how tics occur and can be controlled.

How Is the Trial Designed?

Group I: Medtronic Percept Neurostimulator Experimental Treatment 1 Intervention

This is a deep brain stimulator that can also record brain signals and deliver stimulation through a control algorithm based on brain activity.

Medtronic Percept Neurostimulator is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Medtronic Percept PC for:

• Parkinson's disease
• essential tremor
• dystonia
• epilepsy
• obsessive-compulsive disorder

Approved in European Union as Medtronic Percept PC for:

• Parkinson's disease
• essential tremor
• dystonia
• epilepsy
• obsessive-compulsive disorder

Approved in Japan as Medtronic Percept RC for:

• Parkinson's disease
• essential tremor
• dystonia
• epilepsy

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a long-term follow-up of 5-6 years involving 18 patients with severe Tourette Syndrome, bilateral thalamic deep brain stimulation (DBS) resulted in a significant reduction in tic severity and improvements in obsessive-compulsive behaviors, anxiety, and depressive symptoms, indicating its efficacy as a treatment.

Despite the positive outcomes, there were challenges such as non-compliance and differing satisfaction levels between patients and medical teams, suggesting the need for better patient selection and controlled studies for future DBS interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment of refractory Tourette syndrome: long-term follow-up. Porta, M., Servello, D., Zanaboni, C., et al.[2012]

Deep brain stimulation of the thalamus significantly reduced tic severity in patients with refractory Tourette syndrome, showing a 37% improvement during stimulation and a sustained 49% improvement one year post-surgery, as measured by the Yale Global Tic Severity Scale.

While the stimulation was effective in reducing tics, there were notable adverse effects, including cognitive challenges in attention and energy levels, as well as serious events like a small hemorrhage and infection, highlighting the need for careful consideration of risks in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome. Ackermans, L., Duits, A., van der Linden, C., et al.[2022]

Thalamic deep brain stimulation (DBS) showed significant long-term tic reduction in some patients with Tourette syndrome, with one patient experiencing an 88.9% improvement over 78 months, indicating potential for sustained efficacy.

However, the long-term follow-up revealed increasing side effects, such as reduced energy and visual disturbances, leading some patients to switch off the stimulator or require additional surgeries to change the stimulation target.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thalamic Deep Brain Stimulation for Refractory Tourette Syndrome: Clinical Evidence for Increasing Disbalance of Therapeutic Effects and Side Effects at Long-Term Follow-Up. Smeets, AYJM., Duits, AA., Leentjens, AFG., et al.[2022]

Deep brain stimulation is recognized as a safe and effective treatment for several neurological disorders, including Parkinson's disease, dystonia, tremor, and obsessive-compulsive disorder, with FDA approval for these uses.

Research is expanding into the use of deep brain stimulation for other neuropsychiatric conditions like dementia, depression, and epilepsy, with new targets being explored to enhance treatment for symptoms that do not respond well to traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances and Future Directions of Neuromodulation in Neurologic Disorders. Burns, MR., Chiu, SY., Patel, B., et al.[2021]

Bilateral deep brain stimulation (DBS) of the thalamic CM-Pf complex significantly reduced tic severity in 10 patients with severe, treatment-resistant Tourette syndrome, with an average improvement of 54% over a follow-up period of about 26 months.

The procedure was found to be safe, with no intraoperative complications and manageable postoperative issues, supporting the use of CM-Pf DBS as an effective treatment option for patients with refractory Tourette syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centromedian-Parafascicular Complex Deep Brain Stimulation for Tourette Syndrome: A Retrospective Study. Testini, P., Zhao, CZ., Stead, M., et al.[2018]

Bilateral thalamic deep brain stimulation can lead to significant and sustained tic reduction in Tourette Syndrome patients, with one patient maintaining a 92.6% improvement in tics after 10 years.

While tic reduction was sustained, attention to psychosocial adaptation is crucial, as one patient experienced cognitive decline and increased aggression, highlighting the need for comprehensive post-surgery support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of thalamic deep brain stimulation in two patients with Tourette syndrome. Ackermans, L., Duits, A., Temel, Y., et al.[2022]

Deep brain stimulation (DBS) has shown promising results in reducing tics and improving comorbidities in patients with severe, refractory Tourette's syndrome, particularly in younger adults who experience significant social impairment.

The effectiveness of DBS may depend on the specific target area in the brain, highlighting the need for careful patient selection and target choice, as well as the importance of a skilled multidisciplinary team for managing the complexities of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues related to deep brain stimulation for treatment-refractory Tourette's syndrome. Porta, M., Servello, D., Sassi, M., et al.[2010]

In a study of 6 patients with treatment-refractory Tourette's syndrome who underwent GPi-deep brain stimulation (DBS), 4 patients showed significant functional improvement, as measured by the Global Assessment of Functioning Scale (GAF), with scores increasing from an average of 53.75 to 83.75 over a follow-up period of 12 to 72 months.

The study highlights the importance of assessing psychosocial outcomes alongside tic severity, as improvements in tic symptoms were correlated with enhanced quality of life, indicating that successful DBS treatment can lead to significant psychosocial changes that both patients and clinicians should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcome and quality of life in Tourette's syndrome after deep brain stimulation of the posteroventrolateral globus pallidus internus: long-term follow-up. Dehning, S., Leitner, B., Schennach, R., et al.[2014]

Deep brain stimulation (DBS) significantly reduced tic severity in 25 Japanese patients with refractory Tourette syndrome, showing an average decrease of 45.2% at 1 year and 56.6% at the last follow-up after 3 years, which aligns with international efficacy reports.

While DBS is effective, it carries risks such as dysarthria (32% of patients) and device infection (12%), highlighting the need for careful patient selection and consideration of surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Refractory Tourette Syndrome: Electrode Position and Clinical Outcome. Kimura, Y., Iijima, K., Takayama, Y., et al.[2021]

Deep brain stimulation (DBS) has shown significant clinical improvement in managing tics for individuals with Tourette syndrome, particularly targeting the centromedian thalamus and globus pallidus internus.

Despite the promising results, the current evidence is limited due to small patient numbers and varying study methodologies, prompting the creation of an international registry to standardize data collection and enhance research collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Tourette Syndrome: Potential Role in the Pediatric Population. Deeb, W., Malaty, I.[2021]

Bilateral deep brain stimulation of the centromedian parafascicular complex (CM-Pf) in an adolescent with treatment-resistant Tourette's syndrome led to positive outcomes, including improved adaptive functioning and reduced need for psychiatric medications over 1.5 years.

Neurocognitive testing showed no significant changes, and importantly, the patient reported no suicidal thoughts after the procedure, suggesting that deep brain stimulation can be a safe and effective intervention for severe cases of Tourette's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric Outcome of an Adolescent Who Received Deep Brain Stimulation for Tourette's Syndrome. Pullen, SJ., Wall, CA., Lee, KH., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9261350/

Developments in Deep Brain Stimulators for Successful Aging ...

This work provides an overview of the present state-of-the-art in the development of deep brain Deep Brain Stimulation (DBS) and how such devices alleviate ...

2.

medtronic.com

medtronic.com/content/dam/medtronic-wide/public/united-states/products/neurological/dbs-percept-rc-hcp-brochure.pdf

Percept™ family with BrainSense™ technology

Medtronic DBS therapy is approved for five indications: Parkinson's disease, essential tremor, dystonia*, obsessive-compulsive disorder* (OCD), and epilepsy.

3.

pacificneuroscienceinstitute.org

pacificneuroscienceinstitute.org/movement-disorders/wp-content/uploads/sites/7/2020/12/US-Percept-Media-Kit-US-FY21-FINAL.pdf

MEDTRONIC PERCEPT™ PC NEUROSTIMULATOR ...

* Humanitarian Device: The effectiveness of this device for the treatment of dystonia and obsessive-compulsive disorder has not been demonstrated. † Medtronic ...

4.

medrxiv.org

medrxiv.org/content/10.1101/2025.10.09.25337425v1.full-text

Effective deep brain stimulation for obsessive-compulsive ...

Results Two of the four patients achieved responder status for both OCD and TS. In all four patients, neural variability accurately classified ...

5.

withpower.com

withpower.com/trial/phase-tourette-syndrome-4-2022-a11da

Deep Brain Stimulation for Tourette Syndrome

The Medtronic Percept Neurostimulator is a deep brain stimulation (DBS) device that targets specific brain areas to reduce tics in patients with severe Tourette ...

6.

medtronic.com

medtronic.com/content/dam/medtronic-wide/public/united-states/products/neurological/dbs-percept-rc-media-kit.pdf

Introducing Percept™ RC neurostimulator with ... - Medtronic

Our Percept™ family with exclusive BrainSense™ technology is driving DBS therapy advancement with the goal of many more patients' lives improved.

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED)

The study was a prospective, multicenter, single-arm, aDBS treatment mode blind, randomized crossover trial in subjects with Parkinson's Disease and DBS leads.