Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Battery Replacement Group (for people already using a Parkinson's brain stimulator):

• People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's that does not have a known cause)
• People who already have a Medtronic Activa PC or Activa RC brain stimulator device implanted on both sides of the brain, in a specific brain region called the STN
• People who have had their brain stimulator for at least 3 years and whose device battery will need replacing within 12 months of joining the study
• People who are able to understand and sign a consent form

New Brain Stimulator Group (for people not yet using a brain stimulator):

• People who are 18 years of age or older
• People who have been diagnosed with idiopathic Parkinson's disease that responds to levodopa medication, for at least 5 years
• People whose Parkinson's disease is at stage II, III, or IV on a standard medical staging scale called the Hoehn and Yahr scale (confirm with trial site)
• People who have a documented history of their Parkinson's symptoms improving when they take levodopa
• People who have already been independently selected by their own medical team to receive a brain stimulator in one of two specific brain regions (STN or GPi)
• People whose medical team has independently selected one of a specific list of approved lead models (components of the brain stimulator device) as part of their standard care
• People whose brain stimulator lead wiring has already been checked and confirmed to be working correctly before the battery unit is implanted
• People whose score on a standard memory and thinking test (MoCA) is above 26, assessed when their condition is best managed with medication
• People whose score on a standard mood assessment (BDI-II) is below 17, assessed when their condition is best managed with medication
• People whose Parkinson's motor symptoms improve by at least 33% during a standard levodopa response test
• People who are able to understand what the study involves and have provided written consent to take part
• People who have a responsible caregiver available to help with a 3-day diary, provide feedback on daily activities, and help with attending visits
• People who have been on a stable Parkinson's medication regimen for at least one month before surgery
• People who are willing and able to attend all required study visits and complete all study procedures

Who may not be able to join:

Battery Replacement Group:

• People whose score on a standard thinking and memory test (MoCA) is below 10, indicating severe cognitive decline
• People who have significant psychiatric conditions — such as severe depression or psychosis — that their doctor believes could interfere with the study
• People who have medical conditions that could make battery replacement surgery risky, such as severely high blood pressure, active cancer, or the use of certain blood-thinning medications
• People whose brain stimulator leads (the wires implanted in the brain) need to be replaced or repositioned at the time of the battery replacement procedure
• People who have had more than 10 repeated falls in the 3 months before joining the study
• People who are unable to tolerate having their brain stimulator turned off for at least 30 minutes
• People who are taking less than one dose of levodopa per day
• People whose brain signal recordings (LFPs) are not suitable or are affected by significant interference
• Women who are pregnant or breastfeeding

New Brain Stimulator Group:

• People who have a medical reason why brain stimulator surgery is not suitable for them, including certain brain abnormalities or certain metal implants already in the body
• People who have a history of a suicide attempt, or who are currently experiencing active thoughts of suicide as assessed by a standard clinical scale
• People who have dementia, major depression, seizures, heart failure, uncontrolled diabetes, kidney dialysis needs, substance use disorders, or any other serious medical condition
• People who have any medical condition that could interfere with study procedures or affect the collection of accurate study data
• People who have been diagnosed with a terminal illness where survival is expected to be less than 12 months
• People who need to have repeated MRI scans
• People who require certain types of physical or brain therapy, including diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
• People who already have an electrical or electromagnetic implant in their body, such as a cochlear implant or pacemaker
• People who have, or are planning to have, an implanted electrical stimulation device, an implanted medication pump, or who are currently using a portable medication infusion pump
• People who are on blood-thinning medication that cannot be safely paused for more than 5 days before the surgery to implant the battery unit
• People who have previously had brain surgery, including for Parkinson's symptoms, on either side of the brain
• People who are currently participating in another clinical study (other than a sub-study of this trial)
• Women who are breastfeeding, pregnant, or of childbearing potential who have a positive pregnancy test or are not using adequate contraception
• People whose brain signal recordings (LFPs) are not suitable or are affected by significant interference

Important: Always verify eligibility with the trial site directly before applying.