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Deep Brain Stimulation
Deep Brain Stimulation for Tourette Syndrome
N/A
Recruiting
Led By Michael Okun, MD
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
Study Summary
This trial will test an implantable device that can help suppress tics in people with 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
1,341 Previous Clinical Trials
715,659 Total Patients Enrolled
7 Trials studying Tourette Syndrome
134 Patients Enrolled for Tourette Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,381 Total Patients Enrolled
11 Trials studying Tourette Syndrome
1,760 Patients Enrolled for Tourette Syndrome
Michael Okun, MDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
97 Total Patients Enrolled
2 Trials studying Tourette Syndrome
15 Patients Enrolled for Tourette Syndrome
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spots remaining for this clinical trial?
"Yes, this trial is still accepting participants. The details of the study were uploaded to clinicaltrials.gov on June 20th 2022 and updated most recently on June 29th 2022."
Answered by AI
How many individuals are currently partaking in this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this trial has been open since June 20th 2022 and continues to actively recruit participants. The study is looking for 8 individuals from just one medical centre."
Answered by AI
Are seniors over the age of 80 excluded from participating in this research?
"The age range for enrolment in this clinical trial spans from 18 to 85 years old."
Answered by AI
Am I eligible to partake in this clinical investigation?
"This clinical trial is enrolling 8 individuals aged 18 to 85 who suffer from Tourette syndrome. In order for participants to be eligible, they must meet the following criteria: a Fellowship-trained movement disorders neurologist and psychiatrist must diagnose them with TS in accordance with DSM-V standards; their YGTSS score must be above 35/50 (with the motor tic subscore of >15); their TS symptoms should render them incapacitated due to severe distress, self-injurious behaviour or quality of life disruption (without OCD, depression or ADHD being exclusionary factors); they have attempted therapeutic doses of dopamine blockers and at least"
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
How old are they?
18 - 65
What site did they apply to?
Norman Fixel Institute for Neurological Diseases - University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Tourette’s is something that impacts me on a daily basis. It prevents me from wanting to go to public places when my tics are worse. Lately I’ve had a sniffing facial tic that has made me very self conscious at work as well.
PatientReceived no prior treatments
Because I've struggled with Tourette Syndrome my whole life and nothing has helped. I'm 34 now and it only seems to get worse with age. I feel disabled most of the time, even on days I don't have noticeable tics. It still bothers me and I feel like I'm constantly fighting my body.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Am I too old? Many of these studies don’t want people older than 21. Also, when would I need to travel to Florida and are travel costs covered? (or partially covered?) How invasive is the implant surgery and what is the recovery time? How will this impact my ability to work?
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Norman Fixel Institute for Neurological Diseases - University of Florida: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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