Apathy in Parkinson Disease TMS Study

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 11, 2023

Keywords

ClinConnect Summary

The Apathy in Parkinson Disease TMS Study is a clinical trial that aims to find new ways to help patients with Parkinson's disease who struggle with apathy, which means they have trouble feeling motivated or engaged in activities. The researchers want to see if a treatment called transcranial magnetic stimulation (TMS), which uses magnetic fields to stimulate specific areas of the brain, can improve how patients perform tasks that require effort and whether it can change signals in the brain related to apathy.

To participate in this study, individuals must have a diagnosis of Parkinson's disease for at least five years and be on stable medication for their symptoms. Participants will be asked to fill out questionnaires, complete an effort task, and have their brain activity monitored. They will receive TMS at two different brain locations during separate visits to see if one location is more effective in reducing apathy. The study is currently recruiting individuals aged 20 to 29, and both men and women can join. It's important to note that participants must be able to provide informed consent and have no serious medical conditions that could interfere with the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.