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Deep Brain Stimulation
Deep Brain Stimulation for Tourette Syndrome
N/A
Recruiting
Led By Christopher Butson, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at implantation sites, risk of infection from surgery, possible changes in mood or behavior due to stimulation of brain areas involved in emotion regulation. There might also be risks associated with any surgical procedure such as bleeding or adverse reactions to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Yale Global Tic Severity Scale_(YGTSS) - Total Tic Score
Trial Design
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.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,387 Total Patients Enrolled
7 Trials studying Tourette Syndrome
134 Patients Enrolled for Tourette Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,362 Previous Clinical Trials
650,742 Total Patients Enrolled
12 Trials studying Tourette Syndrome
1,770 Patients Enrolled for Tourette Syndrome
Christopher Butson, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
123 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My Tourette's symptoms didn't improve after trying several recommended medications.I have been diagnosed with Tourette Syndrome by both a specialized neurologist and a psychiatrist.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've been stable on my TS medication for a month without changing the dose, or I've been off TS meds for three months if they were stopped.You have severe tics that greatly affect your daily life and cause a lot of distress. Other mental health conditions like OCD, depression, and ADHD won't prevent you from participating if your tics are the main reason for needing surgery.I have not had brain surgery, metal implants in my head, or any type of implanted stimulator.I have not treated or have unstable mental health conditions like anxiety or depression.I am 18 years old or older.I was offered hormone replacement therapy before joining, and if it works well, I won't need surgery.I will try botulinum toxin treatment for my localized tic before considering surgery.I do not have severe health issues like dementia or abnormal brain scans.My main issue needing surgery is tics, even though I may also have OCD, depression, or ADHD.My tic disorder is severe, causing major distress or harm.My TS symptoms haven't improved with medication, which hasn't changed in a month.My gender does not affect my eligibility for this study.My depression is being treated and is stable.Your diagnosis of TS must be confirmed by a specialized neurologist and a psychiatrist, and it must meet specific criteria in the DSM-V.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic Percept Neurostimulator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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