Status:
RECRUITING
Apathy in Parkinson Disease TMS Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Parkinson Disease
Eligibility:
All Genders
55-80 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
Participants will be asked to come for 3 study visits. During visit 1, after being informed about the study and potential risks, all patients giving written informed consent will undergo a brief cogn...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic Parkinson Disease.
- At least 5 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 stable throughout the study period.
- 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.
Exclusion
- 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 basal ganglia strokes.
- 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.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06087926
Start Date
May 1 2024
End Date
June 30 2027
Last Update
June 19 2025
Active Locations (1)
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1
UNC-Chapel Hill, Cassidy Lab
Chapel Hill, North Carolina, United States, 27599