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Deep Brain Stimulation for Parkinson's Disease
Study Summary
This trial is to study a new way to help those with Parkinson's disease or dystonia using a deep brain stimulator that is controlled by feedback from the brain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can attend all required study visits for my dystonia treatment.You have an implanted device like a pacemaker or neurostimulator.I am not pregnant or have tested negative for pregnancy before my surgery.My Parkinson's symptoms improve when distracted or not observed, and vary widely.I do not abuse drugs or alcohol.I have requested surgery for my dystonia.I have Parkinson's and am considering deep brain stimulation surgery.My MRI does not show any issues that would rule out surgery for Parkinson's.My brain scans do not show any issues that would prevent surgery or suggest a different diagnosis than dystonia.I have Parkinson's but no major health issues that increase surgery risks.I have been on stable doses of my dystonia medication for at least 30 days.I have Parkinson's and need specific brain stimulation treatments.I have Parkinson's and have had brain surgery before.I have Parkinson's with mild thinking or memory problems.I have had brain surgery for my dystonia.I do not have uncontrolled high blood pressure, seizures, heart disease, or conditions that increase surgery risks.I am between 21 and 75 years old and have dystonia.I have dystonia in my face and neck, and botulinum toxin treatments haven't worked well.I have signed a consent form for Parkinson's Disease treatment.I have Parkinson's and my current medication isn't working well, as confirmed by a specialist.My Parkinson's symptoms improve by 30% with medication, and I have at least 2 hours a day of good symptom control.I have Parkinson's with severe, treatment-resistant tremors despite medication.I have been diagnosed with a type of dystonia affecting my neck, head, or entire body.My Parkinson's symptoms are severe enough to need surgery despite medication.My thinking and memory skills are good (MoCA score ≥ 20).You do not have major problems with your thinking and memory, scoring 20 or higher on a test called the Montreal Cognitive Assessment (MoCA).I have signed the consent form for my dystonia treatment.My movement disorder is severe enough to need surgery despite medication.You have a history of misusing drugs or alcohol.You have severe untreated depression or have attempted suicide or have thoughts of harming yourself.I have been diagnosed with Parkinson's Disease for over 4 years.I am between 21 and 75 years old and have Parkinson's Disease.You have mood or personality symptoms that might make it hard for you to participate in the study.You have severe depression that is not being treated, have tried to hurt yourself in the past, or are currently thinking about hurting yourself.If you have Parkinson's disease and have certain implanted devices like cochlear implants, pacemakers, defibrillators, or neurostimulators, you cannot participate.My movement disorder improves when distracted or not observed, and varies over time.I need ECT, rTMS, or diathermy for my dystonia.
- Group 1: Parkinson's disease patients GP Target
- Group 2: Dystonia patients
- Group 3: Parkinson's Disease STN Target
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who meets the eligibility criteria to take part in this clinical experiment?
"Clinicians are looking for 25 adults aged 21 and 75 that suffer from dystonia. In order to be eligible, patients must have movement disorder symptoms severe enough to warrant surgical implantation of deep brain stimulators as per standard clinical criteria, no MR abnormalities contraindicating surgery, the capacity to comply with study protocols including follow-up visits and brain recording tests, absence of cognitive impairment (scoring 20+ on MoCA), signed informed consent if PD is present it should have a minimum duration of 4 years with stable medication doses 30 days prior to baseline assessment."
Does this research include participants younger than 40 years of age?
"As outlined in the trial's inclusion criteria, participants must be between 21 and 75 years of age."
How many participants are involved in this research endeavor?
"Correct. Records on clinicaltrials.gov verify that this medical trial, first posted October 1st 2018, is actively looking for participants. A total of 25 patients must be recruited from one location."
Is this experiment actively accepting participants?
"Data hosted on clinicaltrials.gov denotes that this medical research is actively recruiting individuals, with the study's commencement listed as October 1st 2018 and its most recent update being issued on September 16th 2022."
What are the fundamental goals of this experiment?
"This study is designed to measure the efficacy of open and closed-loop stimulation during chronic adaptive deep brain simulation (DBS) testing at home, with the Toronto Western Spasmodic Torticollis Rating Scale being used for dystonia patients. Further assessments include Hoehn and Yahr Staging in medication 'on' state when using adaptive compared to standard open loop stimulation, as well as Patient's Global Impression of Change scores and resting state EEG recordings which serve as a surrogate marker of alertness."
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