Parkinson's Disease Trial, Recruiting

Written by an AI model from the 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 have signed an informed consent form agreeing to take part in the study
• People who have been diagnosed with idiopathic (no known cause) Parkinson's disease, with movement-related symptoms present for at least 4 years
• People with severe movement problems — such as unpredictable "on/off" periods, involuntary movements, tremor, slowness, or stiffness — that have not been adequately controlled by medication, and whose doctors consider them suitable candidates for deep brain stimulation (DBS) surgery
• People whose movement symptoms score between 20 and 80 on a standard Parkinson's rating scale when off medication, and who show at least 30% improvement on medication — or people with significant tremor that is resistant to treatment and causes major difficulty with daily activities
• People who have tried appropriate Parkinson's medications without adequate relief, as assessed by a specialist, and whose medication doses have been stable for at least 30 days before enrolling
• People who have been reviewed and approved for a specific type of DBS surgery (targeting an area of the brain called the subthalamic nucleus) by the study site's specialist medical team
• People whose brain MRI shows no abnormalities that would suggest a different diagnosis or make surgery unsafe
• People who do not have significant memory or thinking difficulties, and who score 20 or below on a standard depression scale (BDI-II), based on formal neuropsychological testing
• People aged 18 to 80 years (19 to 80 years for participants in Nebraska)
• People who are able to attend all follow-up neurological care exclusively at the study site for the full lifespan of the implanted device (up to 9 years)

Who may not be able to join:

• People with medical conditions that may increase the risk of surgical complications — such as blood clotting disorders, uncontrolled high blood pressure, a history of seizures, heart disease, inability to have general anaesthesia, or who are taking blood-thinning medications that cannot be safely stopped around the time of surgery
• People who are pregnant, or women of childbearing potential who receive a positive pregnancy test before the surgical procedure
• People with significant untreated depression, indicated by a score above 20 on the BDI-II scale or above 8 on the Geriatric Depression Scale (GDS)
• People with personality or mood conditions that the study investigators believe would interfere with participation in the study
• People who require ongoing treatment with electroconvulsive therapy (ECT), a type of brain stimulation called repetitive transcranial magnetic stimulation (rTMS), or a heat-based therapy called diathermy
• People who already have an implanted device such as a cochlear (hearing) implant, a cardiac pacemaker, a defibrillator, or another type of brain or nerve stimulator (for a condition other than Parkinson's disease), or who have any metal implants that are affected by magnets
• People who have previously had brain surgery
• People with a current or past history of drug or alcohol misuse
• People who meet the criteria for Parkinson's disease with mild cognitive impairment (MCI), meaning significant difficulties in two or more areas of thinking and memory, such as attention, problem-solving, language, memory, or spatial awareness, based on formal testing
• People who have Restless Leg Syndrome
• People who have obstructive sleep apnoea
• People who are unable to carry out the recharging process required to operate the specific brain stimulation device used in this trial

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