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:

• People who are 18 years of age or older.
• People who have been diagnosed with advanced Parkinson's disease (PD), confirmed by at least 2 of its 3 main signs: tremor, muscle stiffness, or slowness of movement.
• People who have had Parkinson's disease for 4 years or more.
• People whose medical team has already recommended awake deep brain stimulation (DBS) surgery as part of their standard care, targeting one of two specific brain areas (the subthalamic nucleus or globus pallidus interna).
• People for whom the surgical team has determined that targeting both brain areas at once is a safe option, if that approach is being considered.
• People who are considered healthy enough to safely undergo surgery and participate in the research activities.
• People whose pre-surgery brain MRI scan is normal, or close to normal, aside from mild changes expected with advanced Parkinson's disease.
• People who are willing and able to remain awake and cooperative during DBS surgery, and to attend follow-up visits and medication or device adjustments afterwards.
• People whose health insurance or Medicare covers DBS surgery as part of their routine care.
• People who continue to have significant motor symptoms — such as involuntary movements, wearing off of medication effects, or unpredictable symptom changes — that cause meaningful disability despite reasonable attempts at medication treatment, as assessed by the trial's specialist committee.
• People whose Parkinson's medication doses have remained stable for at least 28 days before their initial assessments.
• People whose motor symptoms improve by 30% or more when assessed using a standard Parkinson's rating scale (MDS-UPDRS Part III) after taking dopaminergic medication — with an exception for those who cannot tolerate levodopa due to unacceptable side effects.
• People whose disease severity is rated above a certain level on the Hoehn and Yahr scale (above stage 2.5), indicating more than very mild, one-sided disease (confirm with trial site).
• People whose daily living difficulties or social and work functioning meet certain thresholds on standard assessment scales when their medication is at its least effective (confirm with trial site for specific score requirements).
• People who score 130 or above on a standard cognitive assessment (the Dementia Rating Scale-2) while on their medications.
• People who score 25 or below on a standard depression questionnaire (Beck Depression Inventory II) while on their medications.
• People who show no signs of suicidal thoughts, as assessed using a standard safety scale.
• People who understand what taking part in the study involves, are available for follow-up appointments for the full length of the study, and have provided signed informed consent.

Who may not be able to join:

• People under 18 years of age.
• People whose insurance will not cover surgery costs involving an investigational device (applies to certain parts of the study only).
• People with medical conditions that make DBS surgery unsafe, such as uncontrolled high blood pressure, certain heart conditions, or blood clotting problems.
• People who have had Parkinson's disease for less than 4 years.
• People whose clinical team expects they will need additional DBS surgery on the other side of the brain within 1 year of having one-sided DBS surgery.
• People suspected or diagnosed with an atypical form of parkinsonism (such as progressive supranuclear palsy, multiple system atrophy, or corticobasal syndrome), medication-caused parkinsonism, or another significant neurological condition other than Parkinson's disease.
• People diagnosed with a psychogenic (non-neurological) movement disorder based on established diagnostic guidelines.
• People for whom, due to their individual brain anatomy or blood vessel arrangement, both brain targets cannot be safely reached through a single surgical opening.
• People who are having DBS electrode placement performed under general anaesthesia without awake brain mapping and testing during the procedure.
• People who score above 25 on the Beck Depression Inventory II, or who have a history of a suicide attempt.
• People who show signs of suicidal thinking or active planning of suicide on the standard safety rating scale.
• People currently experiencing acute psychosis, or who are actively misusing alcohol or drugs.
• People with clinical dementia, indicated by a score of 130 or below on the Mattis Dementia Rating Scale.
• People with an ongoing impulse control disorder (such as compulsive gambling or shopping) that has not improved after reducing their Parkinson's medications.
• People taking blood-thinning medications that cannot be safely stopped around the time of surgery.
• People who have had a bleeding stroke.
• People who currently have, or are at future risk of having, a weakened immune system that could raise the risk of infection.
• People with a history of repeated unprovoked seizures.
• People whose Parkinson's symptoms do not clearly respond to levodopa medication.
• People who already have an implanted medical device, such as a pacemaker, cochlear implant, or another neurostimulator, whether it is switched on or off.
• People who have previously had DBS surgery or a tissue-destroying procedure in the relevant brain area.
• People who have previously had DBS surgery on the opposite side of the brain (applies to certain parts of the study only).
• People who have or are likely to need a medical treatment called diathermy (a form of electrical heat therapy).
• People whose movement disorder is caused by a structural brain problem, such as a stroke in the basal ganglia, a brain tumour, or an abnormal blood vessel.
• People with any medical or psychological condition that the research team determines would prevent them from completing the study.
• People who are pregnant, breastfeeding, or of childbearing potential and not using adequate contraception.

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