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New treatment option for Parkinson Disease
Official title Apathy in Parkinson Disease TMS Study
ClinicalTrials.gov ID: NCT06087926
What this study is testing
- What it's testing
- The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease. The main questions the study aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- Diagnosis of idiopathic Parkinson Disease.
- At least 4 years of symptoms.
- On dopaminergic medication for Parkinson Disease.
- Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant...
- Hospital's study-specific informed consent must be obtained.
You likely can't join if
- Inability to provide informed consent.
- Inability to perform effort task (determined during the titration session).
- Presence of dementia (Montreal Cognitive Assessment (MoCA) score \< 21).
- History of epilepsy or brain surgery.
- Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).
- Patients with clinically significant medical or neurological conditions which may be an alternative cause of parkinsonism such as repeated brain...
See the full eligibility criteria
- Diagnosis of idiopathic Parkinson Disease.
- At least 4 years of symptoms.
- On dopaminergic medication for Parkinson Disease.
- Stable on dopaminergic medication and other medications which may influence apathy (such as selective serotonin re-uptake inhibitors, stimulant medications) for at least 4 weeks prior to first study visit and remain...
- Hospital's study-specific informed consent must be obtained.
- Must have capacity to provide informed consent in English.
- For female participants, confirmation that they have not had a menstrual period in over 12 months, or that they will use an effective form of contraception during the study.
- Inability to provide informed consent.
- Inability to perform effort task (determined during the titration session).
- Presence of dementia (Montreal Cognitive Assessment (MoCA) score \< 21).
- History of epilepsy or brain surgery.
- Severe tremor or dyskinesia that would interfere with EEG (determined by the PI).
- Patients with clinically significant medical or neurological conditions which may be an alternative cause of parkinsonism such as repeated brain injury, anti-dopaminergic medications, anoxic brain injury, or significant...
- Presence of other known central nervous system disease that may interfere with performance or interpretation of EEG or TMS.
- Presence of any implanted metal devices including, but not limited to, pacemakers, deep brain stimulators, vagal nerve stimulators, bladder stimulators, or cochlear implants.
- Presence of medical contraindications to TMS such as implanted stimulators, history of mania or bipolar disorder, history of epilepsy.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.