Deep Brain Stimulation for Tourette Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byMichael Okun, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial involves using a small implantable device to help control severe tics in patients with Tourette syndrome. The device works by monitoring brain activity and sending electrical signals to specific brain areas to stop the tics. This method has been increasingly used for symptom management in severe cases of Tourette syndrome.
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 data supports the effectiveness of the treatment Medtronic Percept Neurostimulator for Tourette Syndrome?
Research shows that deep brain stimulation (DBS) can significantly reduce tic severity in patients with severe Tourette Syndrome who do not respond to other treatments. In one study, patients experienced a 37% improvement in tic severity after DBS, and this effect was sustained with a 49% improvement one year after surgery.
12345Is deep brain stimulation generally safe for humans?
Deep brain stimulation (DBS) has been used safely for various conditions like Parkinson's disease and obsessive-compulsive disorder. In studies for Tourette syndrome, some patients experienced side effects like speech difficulties and infections, but these were generally manageable. Overall, DBS is considered a safe treatment option, though it carries some surgical risks.
34678How is the Medtronic Percept Neurostimulator treatment different from other treatments 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 Syndrome who do not respond to other treatments. Unlike medications, which can have systemic side effects, DBS offers a targeted approach, although it requires surgery and carries risks like infection or bleeding.
1491011Eligibility Criteria
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 am 18 years old or older.
Must be willing to keep TS related medications stable and unchanged throughout the trial.
+5 more
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.
+3 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Medtronic Percept NeurostimulatorExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Norman Fixel Institute for Neurological Diseases - University of FloridaGainesville, FL
Loading ...
Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Issues related to deep brain stimulation for treatment-refractory Tourette's syndrome. [2010]Deep brain stimulation (DBS) has been used in a small number of patients with Tourette's syndrome and results on tics and comorbidities have been promising. The choice of the DBS target appears to influence the effectiveness; preliminary studies and case reports suggest that certain target areas may be more effective than others in patients with specific symptoms and comorbidities. Clinical data on the effect of DBS on tics and behavioral symptoms support its use in patients with severe, refractory Tourette's syndrome, particularly in younger adults who have a greater severity and prevalence of tics and comorbidities, and are more likely to experience social impairment. Although DBS has shown potential as an 'add-on' therapy for Tourette's syndrome patients failing to show adequate improvement with conventional conservative treatments, several issues remain to be resolved, including patient selection, choice of target, and adverse effects. Successful DBS requires an experienced multidisciplinary team for the management of these complex pre-, peri- and postoperative issues. Future studies should include establishment of consistent inclusion criteria and specific practical requirements for clinical trials, evaluation of the impact of DBS on non-tic symptoms and their influence on outcome, social impairment and quality of life, and the identification of optimum neurophysiologically based DBS targets for improved efficacy in specific patient subtypes.
Functional outcome and quality of life in Tourette's syndrome after deep brain stimulation of the posteroventrolateral globus pallidus internus: long-term follow-up. [2014]Deep brain stimulation (DBS) for Tourette's syndrome (TS) in various targets has been in the focus for some years. However, there are hardly any data on "psychosocial" outcome after DBS for TS. The aim of the present study therefore was to focus on the functional outcome and "psychosocial changes" in TS patients after DBS.
Neuropsychiatric Outcome of an Adolescent Who Received Deep Brain Stimulation for Tourette's Syndrome. [2022]This case study followed one adolescent patient who underwent bilateral deep brain stimulation of the centromedian parafascicular complex (CM-Pf) for debilitating, treatment refractory Tourette's syndrome for a period of 1.5 years. Neurocognitive testing showed no significant changes between baseline and follow-up assessments. Psychiatric assessment revealed positive outcomes in overall adaptive functioning and reduction in psychotropic medication load in this patient. Furthermore, despite significant baseline psychiatric comorbidity, this patient reported no suicidal ideation following electrode implantation. Deep brain stimulation is increasingly being used in children and adolescents. This case reports on the positive neurologic and neuropsychiatric outcome of an adolescent male with bilateral CM-Pf stimulation.
Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome. [2022]Deep brain stimulation of the thalamus has been proposed as a therapeutic option in patients with Tourette syndrome who are refractory to pharmacological and psychotherapeutic treatment. Patients with intractable Tourette syndrome were invited to take part in a double-blind randomized cross-over trial assessing the efficacy and safety of stimulation of the centromedian nucleus-substantia periventricularis-nucleus ventro-oralis internus crosspoint in the thalamus. After surgery, the patients were randomly assigned to 3 months stimulation followed by 3 months OFF stimulation (Group A) or vice versa (Group B). The cross-over period was followed by 6 months ON stimulation. Assessments were performed prior to surgery and at 3, 6 months and 1 year after surgery. The primary outcome was a change in tic severity as measured by the Yale Global Tic Severity Scale and the secondary outcome was a change in associated behavioural disorders and mood. Possible cognitive side effects were studied during stimulation ON at 1 year postoperatively. Interim analysis was performed on a sample of six male patients with only one patient randomized to Group B. Tic severity during ON stimulation was significantly lower than during OFF stimulation, with substantial improvement (37%) on the Yale Global Tic Severity Scale (mean 41.1 ± 5.4 versus 25.6 ± 12.8, P = 0.046). The effect of stimulation 1 year after surgery was sustained with significant improvement (49%) on the Yale Global Tic Severity Scale (mean 42.2 ± 3.1 versus 21.5 ± 11.1, P = 0.028) when compared with preoperative assessments. Secondary outcome measures did not show any effect at a group level, either between ON and OFF stimulation or between preoperative assessment and that at 1 year postoperatively. Cognitive re-assessment at 1 year after surgery showed that patients needed more time to complete the Stroop Colour Word Card test. This test measures selective attention and response inhibition. Serious adverse events included one small haemorrhage ventral to the tip of the electrode, one infection of the pulse generator, subjective gaze disturbances and reduction of energy levels in all patients. The present preliminary findings suggest that stimulation of the centromedian nucleus-substantia periventricularis-nucleus ventro-oralis internus crosspoint may reduce tic severity in refractory Tourette syndrome, but there is the risk of adverse effects related to oculomotor function and energy levels. Further randomized controlled trials on other targets are urgently needed since the search for the optimal one is still ongoing.
Deep brain stimulation for treatment of refractory Tourette syndrome: long-term follow-up. [2012]Eighteen patients with severe and refractory Tourette Syndrome underwent bilateral thalamic deep brain stimulation. The surgical procedures and stimulation processes of the cohort were reported in 2008; the 2 year follow-up was reported in 2009. The aim of the research is the assessment of long-term outcome (5-6 years) on tics, obsessional behaviours, anxiety, mood, and on the overall general health of the patients and their general satisfaction.
Advances and Future Directions of Neuromodulation in Neurologic Disorders. [2021]"Deep brain stimulation is a safe and effective therapy for the management of a variety of neurologic conditions with Food and Drug Administration or humanitarian exception approval for Parkinson disease, dystonia, tremor, and obsessive-compulsive disorder. Advances in neurophysiology, neuroimaging, and technology have driven increasing interest in the potential benefits of neurostimulation in other neuropsychiatric conditions including dementia, depression, pain, Tourette syndrome, and epilepsy, among others. New anatomic or combined targets are being investigated in these conditions to improve symptoms refractory to medications or standard stimulation."
Centromedian-Parafascicular Complex Deep Brain Stimulation for Tourette Syndrome: A Retrospective Study. [2018]Deep brain stimulation (DBS) of the thalamic centromedian/parafascicular (CM-Pf) complex has been reported as a promising treatment for patients with severe, treatment-resistant Tourette syndrome (TS). In this study, safety and clinical outcomes of bilateral thalamic CM-Pf DBS were reviewed in a series of 12 consecutive patients with medically refractory TS, 11 of whom met the criteria of postsurgical follow-up at our institution for at least 2 months. Five patients were followed for a year or longer. Consistent with many patients with TS, all patients had psychiatric comorbidities. Tic severity and frequency were measured by using the Yale Global Tic Severity Scale (YGTSS) over time (average, 26 months) in 10 subjects. One patient was tested at 2-week follow-up only and thus was excluded from group YGTSS analysis. Final YGTSS scores differed significantly from the preoperative baseline score. The average (n=10) improvement relative to baseline in the total score was 54% (95% CI, 37-70); average improvement relative to baseline in the YGTSS Motor tic, Phonic tic, and Impairment subtests was 46% (95% CI, 34-64), 52% (95% CI, 34-72), and 59% (95% CI, 39-78), respectively. There were no intraoperative complications. After surgery, 1 subject underwent wound revision because of a scalp erosion and wound infection; the implanted DBS system was successfully salvaged with surgical revision and combined antibiotic therapy. Stimulation-induced adverse effects did not prevent the use of the DBS system, although 1 subject is undergoing a trial period with the stimulator off. This surgical series adds to the literature on CM-Pf DBS and supports its use as an effective and safe therapeutic option for severe refractory TS.
Deep Brain Stimulation for Refractory Tourette Syndrome: Electrode Position and Clinical Outcome. [2021]The efficacy of deep brain stimulation (DBS) for refractory Tourette syndrome (TS) is accepted, but whether the efficacy of DBS treatment in the Japanese population is equivalent to those reported internationally and whether adverse effects are comparable are not yet known. This study evaluated the clinical practice and outcome of DBS for TS in a Japanese institution. This study included 25 consecutive patients with refractory TS treated with thalamic centromedian-parafascicular nucleus DBS. The severity of tics was evaluated with the Yale Global Tic Severity Scale (YGTSS) before surgery, at 1 year after surgery, and at the last follow-up of 3 years or more after surgery. The occurrence of adverse events, active contact locations, and stimulation conditions were also evaluated. YGTSS tic severity score decreased by average 45.2% at 1 year, and by 56.6% at the last follow-up. The reduction was significant for all aspects of the scores including motor tics, phonic tics, and impairment. The mean coordinates of active contacts were 7.62 mm lateral to the midline, 3.28 mm posterior to the midcommissural point, and 3.41 mm above anterior commissure-posterior commissure plane. Efficacy and stimulation conditions were equivalent to international reports. The stimulation-induced side effects included dysarthria (32.0%) and paresthesia (12.0%). Device infection occurred in three patients (12.0%) as a surgical complication. The DBS device was removed because of infection in two patients. DBS is an effective treatment for refractory TS, although careful indication is necessary because of the surgical risks and unknown long-term outcome.
Long-term outcome of thalamic deep brain stimulation in two patients with Tourette syndrome. [2022]Thalamic deep brain stimulation for intractable Tourette Syndrome was introduced in 1999 by Vandewalle et al. In this follow-up study, the authors report on the long-term (6 and 10 years) outcome in terms of tic reduction, cognition, mood and side effects of medial thalamic deep brain stimulation in two previously described Tourette patients.
Deep Brain Stimulation for Tourette Syndrome: Potential Role in the Pediatric Population. [2021]Tourette syndrome (TS) is a complex neuropsychiatric disorder. Despite an expected natural history of improvement with age, many individuals continue to have severe tics and remain refractory to the current best pharmacologic and nonpharmacologic treatments. Deep brain stimulation (DBS) has emerged as a potential treatment option. This article reviews the published reports on the use of deep brain stimulation in Tourette syndrome revealing that 2 anatomical targets have been most commonly used: the centromedian thalamus and the globus pallidus internus. The evidence supports a significant clinical improvement of tics with deep brain stimulation, though the data are limited by the small number of patients and variable methodology employed. To bridge these limitations, the international Tourette syndrome deep brain stimulation database and registry have been created, fostering collaboration among multiple centers from 10 countries. By standardizing data collection, the database and registry are providing valuable insights into deep brain stimulation for Tourette syndrome. In conclusion, deep brain stimulation offers significant promise for the management of tics.
Thalamic Deep Brain Stimulation for Refractory Tourette Syndrome: Clinical Evidence for Increasing Disbalance of Therapeutic Effects and Side Effects at Long-Term Follow-Up. [2022]Thalamic deep brain stimulation (DBS) is effective in reducing tics in patients with refractory Tourette syndrome at the short-term. Here, we report on the long-term outcome.