Investigational Brain Stimulation Target: Centromedian Nucleus (CMT) / Parafasicular Complex (Pf) / Ventral Oral Nucleus (Voa) / Substantia Paraventricularis (Spv) of the Thalamus
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Okun (2013) |
A Trial of Scheduled Deep Brain Stimulation for Tourette Syndrome: Moving Away From Continuous Deep Brain Stimulation Paradigms |
United States --- • National Institutes of Health |
Condition after Bilateral CMT Stimulation vs Condition without Stimulation vs Condition before Implantation
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5 |
• Adults (≥25 years old) • Severe disabling Tourette syndrome • No response to at least 4 drugs • No untreated mood disorder or psychosis • No severe medical conditions • No recent illicit drug use • No prior neurosurgical intervention • No neurological disorder
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Double Blinded Crossover Study followed by a Prospective Cohort Study Approved by the Institutional Review Board
Length: 6 months
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• Significant improvement seen at 6 months (average of 18.6% improvement • Improvement delayed in patients randomized to group with delayed stimulation • Immediate effect of scheduled stimulation was found to be comparable to the immediate effect of continuous stimulation Major Adverse Events: • None
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Porta (2012) |
Deep brain stimulation for treatment of refractory Tourette syndrome: long-term follow-up |
Italy --- • Italian Tourette Syndrome Association • National Hospital Research Development Fund |
Condition after Bilateral CM-Pf-Voa vs Condition before Implantation |
18 |
• Patients ages 17-47 • Severe disabling Tourette syndrome • No response to at least 6 months medical treatment with at least 2 drugs • No severe medical conditions
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Prospective Cohort Study Approved by the Institutional Ethical Standards Committee
Length: ≥ 5 years |
• Significant improvement seen at 36 months (average of 35.5% improvement) • 50% patients had at least a 35% improvement in their OCD score • Improvement in concurrent depression (average of 27.0% improvement) • Improvement in concurrent anxiety (average of 56.0% improvement) • Improvement in overall daily function (average of 32.0% improvement) Major Adverse Events: • Intracranial hemorrhage (1/8) • Discontinued stimulation due to lack of adequate therapeutic effects (2/8)
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Savica (2012) |
Deep Brain Stimulation in Tourette syndrome: A Description of 3 Patients With Excellent Outcome
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United States --- • National Institutes of Health |
Condition after Bilateral CMT-Pf Stimulation vs Condition before Implantation |
3 |
• Patients ages 17-35 • Severe Tourette syndrome • No response to at least 5 drugs • No response to behavioral therapy • Stable ADHD
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Case Series
Approved by the Institutional Review Board
Length: 12 months
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• Significant improvement seen at 12 months (average of 70% improvement) • Some immediate improvement of tics • Concurrent psychiatric symptoms remained stable or slightly improved Major Adverse Events: • None |
Ackermans (2010) |
Double-blind clinical trial of thalamic stimulation in patients with Tourette syndrome |
Belgium The Netherlands --- none mentioned
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Condition after Bilateral CM-Vca-Spv vs Condition without Stimulation vs Condition before Implantation |
6 |
• Adults (≥25 years old) • Severe Tourette syndrome • No response to 3 month trials of at least 3 different medications • No response to 10 sessions of behavioral therapy • No psychiatric disorder • No current substance use • No structural brain abnormalities
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Double Blinded Randomized Crossover Study Approved by the Institutional Ethics Committee
Length: 12 months (3 month crossover)
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• Blinded phase demonstrated significant improvement only in patients receiving stimulation (average of 37% more than those without stimulation) • Significant improvement seen at 12 months (average 49.2% improvement) • No effect on cognition • No significant improvement in concurrent ADHD, OCD, Anxiety, or Depression
Major Adverse Eventts: • Brain hemorrhage (1/6) • Infection (1/6) • Decreased energy level (6/6) • Blurry or double vision (6/6) |
Visser-Vandewalle (2003) |
Chronic bilateral thalamic stimulation: a new therapeutic approach in intractable Tourette syndrome. Report of three cases
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Belgium The Netherlands --- none mentioned |
Condition after Bilateral CMT-Pf Stimulation vs Condition before Implantation |
3 |
• Patients ages 28-45 • Severe Tourette syndrome • No response to multiple medications • No response to behavioral therapy • No severe medical conditions |
Case Series Approved by the Institutional Ethics Committee
Length: 26.7± 28.9 months (range 8-60 months)
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• Significant reduction in tics after long-term follow-up (average of 82%)
Major Adverse Events: • None
Side Effects: • Decreased energy level (3/3) • Increase Sexual Drive (1/3) |
Investigational Brain Stimulation Target: Globus Pallidus pars interna (GPi)
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Cannon (2012) |
Deep brain stimulation of anteromedial globus pallidus interna for severe Tourette's syndrome
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Australia --- • •Medtronic, Inc. • New South Wales Institute of Psychiatry Training Fellowship • National Health and Medical Research Council of Australia Program |
Condition after Bilateral GPi Stimulation vs Condition before Implantation |
11 |
• Adults (≥18 years old) • Severe Disabling Tourette syndrome • No response to at least 3 drugs • No response to behavioral therapy
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Prospective Cohort Study Approved by the Institutional Review Boad
Length: ≥3 months
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• Significant improvement seen at 3 months (average of 49.6% improvement) • 54.5% had at least 50% improvement in their tic severity score • 92% reported improvement within 3 days of surgery
•Significant improvement in concurrent Depression (average of 60.2% improvement) •Significant improvement in concurrent OCD (average of 56.9% improvement)
Major Adverse Events: • Worsening tics (1/11) • Worsening Depression or Anxiety (2/11) • Hardware malfunction (3/11) • Infection (1/11) |
Multiple Stimulation Locations
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Welter (2008) |
Internal pallidal and thalamic stimulation in patients with Tourette syndrome
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France --- • National Institute of Health and Medical Research (INSERM) • University of Pierre and Marie Curie (Paris VI) • Assistance-Publique-Hôpitaux de Paris
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Condition after Bilateral Gpi Stimulation vs Condition after Bilateral CM-Pf Stimulation vs Condition after Bilateral Stimulation of Gpi & CM-Pf vs Condition without Stimulation
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3 |
• Adults (≥18 years old) • Severe Disabling Tourette syndrome • No response to at least 6 months medical treatment • No cognitive deficits • No psychosis |
Controlled Double Blinded Randomized Crossover Study
Approved by INSERM and Institutional Ethics Committee
Length: 37.7± 20.4 months
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•The most significant improvement was seen with Gpi stimulation (average of 78.3% improvement) • Significant improvement was seen with CM-Pf stimulation (average of 44.7% improvement) • Significant improvement was seen with stimulation of both (average of 59.7%) • In 2 patients, turning off stimulation resulted in return of symptoms nearly to baseline levels • No negative effect on cognition • Decrease in Depression and Anxiety with CM-Pf stimulation
Major Adverse Events: • Decreased energy level (3/3) • Numbness of face/arm (3/3) • Nausea/Vertigo (2/3) • Decreased libido (1/3) |